Hello and welcome to the 43rd Annual JPMorgan Healthcare Conference. My name is Michelle Hang, and I am an associate here with JPMorgan's Healthcare Investment Banking Group. It is my pleasure to introduce Anika Therapeutics today. We have here with us CEO Cheryl Blanchard and CFO and Treasurer Steve Griffin. I will now turn it over to the team to tell us more.
Thank you, Michelle. Thanks, everybody, for joining us today. I'm really excited to be here, and I'd like to thank J.P. Morgan for the opportunity to tell Anika's refreshed strategic story. We're very excited today to be able to talk to you. Let me show you the Safe Harbor statement. We're very excited today to be able to talk to you about the company and about what we're doing with our refreshed strategy. We've been through a significant amount of work this year. We're in the process of divesting a couple of assets. One is done, one is in process, and I'm going to focus today on the go-forward strategy that this management team is very excited about. Anika is a global leader in two verticals from a therapeutic perspective: the osteoarthritis pain management space and the regenerative solutions space, all focused on early intervention orthopedics.
Anika is a company that has developed highly differentiated and proprietary hyaluronic acid technology, and all of our products leverage that and play into very exciting markets. I'm going to get into that in a bit. We have a significant opportunity in front of us now to unlock a lot of value, and we're going to do that. I'm going to talk to you about it in detail today, but we're going to do that by continuing to launch products into spaces where there remain high unmet patient need, high unmet clinical need, with products that are differentiated, that have significant features and benefits that the patients want, that the surgeons want, and where there's an opportunity and a marketplace to drive value for our shareholders.
We're going to do this in the near term, the midterm, and the short term, and I'm going to talk to you about those products and kind of the timing of the progression of those value-building opportunities. The first thing I'll mention is, in our space we operate in today with osteoarthritis pain, we play into a $1 billion-plus market in the United States, a very large market outside the United States where we've been growing that business double digits over a significant period of time. But we also have an opportunity in front of us with our currently launched Integrity Implant System, our regenerative rotator cuff repair product that is currently playing into over a $200 million addressable market and gaining a lot of traction. I'm going to talk in more detail about that product.
And then we've got real near-term opportunities as we bring Hyalofast through our PMA process with the FDA. We've begun filing our modular PMA. We will finish filing it this year with our breakthrough device designation, and we will launch that product, anticipate launching that product by 2026. That is real line of sight. It's right in front of us. That's a product that we sell in over 35 countries today, and bringing that into the United States will give us an additional billion-dollar addressable market opportunity. And then longer term, our next-generation osteoarthritis pain product, Cingal. I'm going to talk more about Cingal today. I have a bit of an update on that program. That, again, is a product that we sell in over 40 countries outside the United States today.
Bringing that to the United States and getting FDA approval for that product adds an additional $1 billion to our addressable market opportunity. The company is in a very strong financial position. We have cash. We have no debt. And with our osteoarthritis pain products and the products that we're selling today, we have very strong cash flow that will fund our growth opportunities in the regen solutions space and with Cingal in the United States. So I'm going to dig into our products. First, I want to give you a quick overview about our technologies. I mentioned that Anika has really built our story based on our proprietary hyaluronic acid technology, and that's in kind of two buckets: our gel products that are our OA pain management products on the top of this slide, Orthovisc, Monovisc, and Cingal. Orthovisc and Monovisc have very strong clinical data.
They occupy the number one market share position in the United States, and Cingal is sold in over 40 countries outside the United States. Combining Monovisc, which is our single injection product, with a steroid, triamcinolone hexacetonide, we have an incredible next-generation osteoarthritis pain product with clinical data that I'm going to show you here in a bit. Those are our gel products, and we will continue to leverage that technology. Again, those are very profitable products for us, and that cash flow is funding the ongoing development and launch of our Cingal in the U.S. and our regenerative products. Down below, our regenerative solutions products. The other base technology that we have at Anika we call HYAFF. It's a chemically modified version of hyaluronic acid. We esterify it.
We essentially turn it into a polymer, and that allows us to spin fibers and make wovens, knitted structures, and non-wovens. Integrity, our implant system for rotator cuff repair and other tendon applications, is a knitted version of HYAFF that also includes some polyethylene terephthalate (PET) in it. Hyalofast is the non-woven version of HYAFF, and that's our single-stage cartilage repair product. And then we have a bone product called TactoSet that is an injectable settable bone void filler. So all of these products occupy our regenerative solutions portfolio, and we have additional products under development that will be coming soon. Some of them are effectively line extensions of Integrity, different shapes and sizes that will allow us to treat different anatomies. So that's an overview of our products, the base technology that the company has, and how we're leveraging that.
Now let me speak to how those products really play into addressable markets and the significant market opportunity and the ability to unlock value that we have in front of us right now. So I'll start at the bottom with Monovisc and Orthovisc. Those two products play into a $1 billion addressable market in the United States, a significant market outside the United States. Outside the United States, we've continued to grow those products in addition to Cingal double digits. So that's our current market opportunity today. Another current market opportunity today is with the Integrity Implant System. We are selling that implant into about a $220 million addressable market in the U.S. right now. That's a near-term opportunity for us. We have that product in full market release.
It continues to perform very well with 40% sequential growth, and we look forward to continuing to bring line extensions to that that we think will give us additional market expansion opportunities. Then Hyalofast. Hyalofast is next. It's next in terms of timing. We're in process, on time to launch that by 2026. This year, we work to bring that through the FDA. That is a product we sell outside the United States, but in the United States gives us an additional billion-dollar addressable market opportunity. Then Cingal, which is longer term. We continue to work through the FDA with Cingal, again, bringing that to the United States, an additional billion-dollar market opportunity. So we're driving toward having access to a $3 billion-plus set of market opportunities.
Let me dive into the product categories and speak to why we think these are our great products, why they're differentiated, and why we think we have the opportunity to really drive a lot of shareholder value. I'll start out with our viscosupplement products, Monovisc and Orthovisc, and what you see here is the fact that we have, with our partner J&J MedTech, combined a number one market share position in the viscosupplement space, that billion-dollar market opportunity that we have in the United States. These are great products. They have great clinical data. They have been in the market for a number of years in the United States. They're very profitable products for us. They deliver significant cash flow, and they give us an opportunity to continue to invest in bringing growth products into the market.
Outside the United States, along with Cingal, we are taking share, and we're driving double-digit growth in our OA pain portfolio, so we look forward to bringing Cingal into the United States, into this OA pain management portfolio, and continuing to drive growth here. I would note that in recent quarters, the J&J business has softened a bit due to market access challenges and pricing challenges, but they are working hard to bring that back in line so that we are back sort of at market by 2026 and stabilizing that business. That said, that business is highly cash generative, even in spite of the softening that's occurred in recent quarters, and we look forward to our partner, J&J MedTech, stabilizing that business so that we can continue to benefit from the significant cash flow that we derive from that business today.
Now I'll switch over to the regenerative products, our Integrity Implant System. This is a product that we're incredibly excited about. It's here. It's real. It's now. It's in the U.S. market in full market release. This is playing into about a $220 million addressable market as it stands today, we think, with market expansion opportunities. We developed this implant primarily to treat rotator cuff pathology, and we developed instrumentation and a very streamlined surgical lateral-first surgical technique. The surgeons are loving it. It's being widely adopted. We're seeing 40% sequential growth with this product. The reason for that, we did a head-to-head animal study with the market-leading product, a first-generation collagen implant, demonstrating that we have three times the regenerative capacity as those first-generation collagen implants. We also have an implant that is strong. It's strong at time zero.
It stays strong while the rotator cuff regenerates, and it's very easy to use. It has good strength, even suture retention strength when wet, so we're very excited about this product. We've now completed, this is an update, 750 cases since launch and are continuing to see 40% sequential growth, very excited also to get additional shapes and sizes of Integrity launched this year that will allow us to play more in the foot and ankle market and other anatomies that we'll talk about when we get to those product launches. Now I'll switch over to Hyalofast. Hyalofast is our single-stage cartilage repair product. We're also incredibly excited about this. This has been a long time in clinical development to bring this product to the United States.
It's been for sale outside the United States for over 15 years, and we actually just this year had clinical data published with 15-year data. So we'll be launching this product in the United States with 15-year data and a level one study that we're using in the United States to file for FDA approval. So this product will play into a very healthy market that Vericel primarily occupies with their MACI product. They just pre-announced that they hit almost $200 million with that product last year. It's a product that is, it's supremely expensive. It's $50,000-$60,000 for the product. It requires two separate surgeries. So the patient gets a biopsy taken in the first surgery and comes back some weeks later for a full second surgery. This product is off the shelf. It literally has shelf life. Surgeons are grabbing it off the shelf.
They'll be able to use it in surgeries, which is most of the cartilage lesions that are found where they're in there doing an ACL repair, a meniscectomy, and they see a cartilage lesion, they can grab Hyalofast and treat that cartilage lesion where they might not today because they don't want to put the patient through a second surgery with a very expensive product. This product is easy to use. You can cut it. You can fold it. It will work for chondral and osteochondral lesions. So we have access to that full cartilage repair market. And we think because it's so easy to use and it's off the shelf and it won't be $50,000-$60,000 for the product itself, that there are real market expansion opportunities. We're talking about a billion-dollar-plus market opportunity, but we think there's real opportunity here to continue to expand that market.
We filed the first PMA module last year. We have two more PMA modules to file, which we will file this year, the last one being the clinical module. We have last patient out coming up soon, and we will continue to get those modules filed. We are on track for getting those modules filed this year and launching this product by 2026. We think this provides a real opportunity to unlock value in the near term. The next thing I want to talk about is Cingal. Cingal is our next-generation osteoarthritis pain product. It is incredibly powerful. This is clinical data that is really unparalleled. The only other thing in the United States available today that really fits into that next-generation OA pain product category is Zilretta. It's a long-acting steroid. You can see here that Zilretta begins to return to baseline right around the four-week point.
Cingal is both fast-acting because of the triamcinolone hexacetonide steroid that we have in Cingal and long-lasting. And you can see here the data out to six months. It shows no signs of returning back to baseline even at six months. It's also very safe. It's a non-opioid. It's non-addictive. And we have delivered over 775,000 doses outside the United States in over 40 countries where we sell the product today. We also know because there's HA in it, we've done a lot of basic science around this, that this product is chondroprotective and it is safe for repeat use. So we're very excited to continue on our pathway to get over the hurdles, over the filing issues, to get the NDA filed. I do have an update on this program.
We have a Type C meeting scheduled this quarter with FDA to get final definition around the study design for the bioequivalence data that the FDA is looking for around the 505(b)(2) pathway for the TH component in Cingal, so we are making progress on this program, very excited, continue to see this product relative to the clinical data, a product that addresses real unmet need with a minimally invasive injection for osteoarthritis patients, so let me cover the financials. I want to make sure we leave time for questions here. What I've got up here right now, I want to talk to you about our revenue going forward, and we talk about our revenue in two different categories. We have our commercial channel and our OEM channel, and that's basically the two different ways that we sell our products.
Our commercial channel includes our regenerative solutions products globally and our international OA pain management because that's a part of our pain management business that we manage. That's a business that has grown with a 17% CAGR since 2021. We see that business continuing to grow in strong double digits going forward. You can see in the out years, we're looking at greater than 20% growth. Our OEM channel includes our U.S. Monovisc and Orthovisc and our non-orthopedic products. You see with that business that we see some moderation of it in the out years and then stabilization of it. Again, this is our high-margin, highly cash generative business. It really enables us to invest in our growth opportunities without having to raise capital.
What we're aiming to do here is continue to diversify our revenue stream away from this OEM channel and the dependence on those long-term contracts where we have partners that control pricing, sales, and marketing to our commercial channel where we have control over those things, where we're capturing the full value stream from a margin perspective and with the opportunity for margin expansion as we begin to continue to grow those regenerative solutions products, so our commercial channel revenue we project to be about half of our full revenue stream by 2026, so we're making good progress in that revenue diversification process. We've highlighted here our guidance, which we're reaffirming in today's presentation, and this really represents the same growth that I just spoke about on the prior slides.
I would point out here on the OEM channel that you just saw that we're expecting that to be lower in 2024 and 2025. That's primarily due to those near-term competitive dynamics that I mentioned in the U.S. that our partner J&J is really working to offset, and we expect that will drive stabilization when we get to 2026. We expect our profitability to remain in the low double-digit adjusted EBITDA margins range as we generate strong returns from that OA pain management channel and as we really begin to grow the regenerative piece of our business. Again, we're in a very strong financial position. We don't need to raise capital. We have over $60 million of cash on the balance sheet as of Q3.
And the fact that we don't need to access capital markets and we can fund our own growth strategy, we think is very exciting and is another lever that allows us to continue to unlock value. I will tell you that the investments that we're making there, we've done a lot of work around looking at where those investments should be made to maximize shareholder value and maximize our ROIC. So I'd like to summarize by kind of walking you through, again, those three strategies that are really timeline-focused. We think our story is an exciting one.
We've spent a lot of time in the last year refocusing that strategy, kind of clearing the smoke so that you can all see the inherent value that we have here with a piece of our business that is very cash flow positive, cash generative, allows us to fund a growth strategy with highly differentiated products that have superior clinical data and really offer benefits and features both to patients and to our customers. We think that's really the key for us to drive shareholder value. We're going to do that in the near term by continuing to deliver our OA pain management products and really driving our Integrity Implant System that is fully launched in the United States that we're already seeing, even though early days, 40% sequential growth. That's playing into that $220 million tendon augmentation market.
We'll be launching additional shapes and sizes for that product this year. We're very excited about continuing to grow that in the near term this year. Midterm, next year, 2026, not that far away. We continue to work on our modular PMA with our breakthrough device designation of Hyalofast, our single-stage cartilage repair product that's going to sell into an already created market in the United States, but in a way where it's highly differentiated, off the shelf, single-stage, with a much more attractive price point than the current product that's out there. This will be sold through our channel, through our commercial channel, and address an additional $1 billion addressable market opportunity for us in the United States.
And then longer term, as we continue to work to get Cingal approved in the FDA, bringing Cingal to the United States, a product we sell in over 40 countries today that has driven double-digit growth for us in those markets outside the United States, addressing an additional $1 billion market opportunity in the United States with that OA pain management segment. I would close by telling you we've spent the last year really focused on allocating our resources for the areas that we think are going to bring the highest growth and the highest value unlocking opportunities for our shareholders. And we're going to do that by focusing on products that are highly differentiated, that really bring value to our customers and their patients. And we think that's the key to unlocking value for Anika. Thank you very much for the opportunity. We'll take questions. Thank you.
We will now take any questions from the audience or through the webcast. I'm also happy to kick things off. So you talked a little bit about the Integrity Implant System, and it appears to be doing very well. It's growing very fast. Can you maybe talk a little bit more about what is driving its growth and how it's been received by different surgeons relative to its competitors?
Yeah, absolutely. One of my favorite topics to talk about. So we really looked at the tendon repair market and recognized that there were still significant unmet needs there. There are products out there that are regenerative. They're all based on first-generation collagen technology, which is a regenerative biomaterial. And those products have carved out a nice market. But what we began hearing from surgeons was those products don't have any strength. You get them wet and they're like tissue paper.
They don't hold a suture. And we'd really like something that gives us the confidence in both the mechanical reconstruction of the tendon repair, but also something that's going to contribute significantly to the biology. And what we're hearing back from surgeons is that we have accomplished that with Integrity. They're finding that they feel very confident about their biomechanical reconstruction when they do the rotator cuff repair. And they're seeing incredible clinical results. We're getting close to publishing our first post-market study results. We've got two surgeons doing studies. One of them is more focused on clinical outcomes. The other one's more focused on MRI results. But the feedback that we're getting, and there's videos all over LinkedIn of post-operative results with patients like six weeks out, back to full function with their rotator cuff.
So I think what this is doing is giving surgeons the confidence to really adopt the hyaluronic acid technology, which is a new regenerative biomaterial for them in this application. It's not new to them from an injection perspective. But I think that's really what's driving the 40% sequential growth. We're also seeing a lot of new customers coming into Anika. A significant portion of the product is being used by very new relationships to Anika. So we look forward to continuing to grow this product, to continue to drive line extensions. It's already being used in the foot and ankle. It's being used in the knee. It's been used in a number of places for tendon augmentation.
And so now we're focused on making sure that we provide the right shape, size, geometry, etc., that are really tailored to those other tendon augmentation indications so we can continue to grow. Thank you.
Yes. I have two questions regarding the regenerative medicine area. So I noticed Hyalofast actually is at their PMA process. It's a medical device. And the Vericel MACI actually is at their BLA process. It's more like a drug. So I want to know more about what will be the physician's choice between my device versus a biologics product. Is there any difference from kind of a decision-making point of view, but also on the commercialization, like sales and marketing point of view?
Your question was on Hyalofast and the fact that Hyalofast is a biologic.
And you're asking how that compares to, I'm sorry, that Vericel's MACI is a biologic. And okay. So Hyalofast is actually a biologic also. It's a PMA, but it's a PMA through CBER. So Hyalofast gets used with BMAC, bone marrow aspirate concentrate, which makes it a biologic. So our PMA will be through CBER. It's a drug, sorry, a device biologic combination product with a PMA process through CBER. The MACI product is a cell therapy. It is fully a biologic, but it has a collagen scaffold. So there's a device component to theirs too. So it's actually a similar pathway through the FDA. I think your other question was also how the surgeons would receive it. The surgeons love Hyalofast. We sell it outside the United States. It's their favorite product. We have surgeons in the U.S. clamoring for this product right now.
We're already off and running with doing our commercial launch preparation and engaging clinicians. There's a very long list of surgeons that are ready to have this in their OR and to be able to pull it off the shelf and use it in their cartilage repair procedures. Did that fully answer your question? Because I may have missed some parts of it. For products under medical device route and the other ones more like a biologic drug, is the physician, when they're choosing the product, is there any difference? Also from a sales and marketing perspective or even reimbursement perspective, any difference between these two sectors, even though the concept or the mechanism is very similar? Yeah, in terms of the sales process, that won't be different. Anika will be selling it. We have a sales force.
We'll sell it through that sales force as we continue to invest and grow that sales force in preparation for the Hyalofast launch, but it is a surgical cell just like the MACI product is. From a reimbursement perspective, once we get FDA approval, we'll be able to file for our reimbursement code. We'll begin selling immediately, though there's the opportunity to sell before you get a reimbursement code, but the reimbursement code really fully opens up the market. All of those activities are in progress right now. Can we leverage their reimbursement code? I think they did a pretty good job on this part. Vericel's reimbursement code. Leverage their code. No, they have a code that is specific to a cell therapy. So we'll have to get a separate code. Yeah, and that process is in preparation, and we will do it.
You can't start the process until you get FDA approval. Yeah. So one more question. Actually, you leverage a lot of outside U.S. data to try to launch the products in the U.S. We also know there are a few other guys doing a similar thing like Vericel in Europe. They are also trying to launch their products in the U.S. by leveraging outside U.S. data to support a BLA without U.S. pivotal trial. So do you foresee those could be a potential way to register product here and also be a potential competitor for Hyalofast? So the clinical, we have a lot of clinical data on Hyalofast. We have over 40 clinical publications because of the OUS usage. That will support our application with the FDA. But we ran an IDE study in the United States.
We did have sites globally, but we ran a randomized controlled clinical trial compared to microfracture, and that's the clinical data that we will use in our FDA submission and for marketing purposes.
Thank you very much. Are there any other questions from the audience? Maybe we can switch gears a little bit and talk about Cingal. Cingal, it's compelling compared to the current next-generation OA pain product that's on the market here in the United States. Can you tell us about how Cingal has been performing outside of the United States alongside other products as kind of a reference point for insight? Yeah, absolutely. I'm always excited to talk about Cingal. It's a product that when we launched it, I think it was way before my time, the company knew how great the clinical data was and was excited to launch it outside the United States.
But we launched it into countries where Monovisc was already approved and for sale. And one of the questions I get is, is Cingal going to cannibalize Monovisc? We have never seen Cingal cannibalize Monovisc. And the reason for that is it gets used instead of a steroid. So it's really taking steroid procedures that is a low dollar value market for a premium price product that really has highly differentiated clinical data. Because a steroid is a short-acting and something that you can't use on repeat injection forever because it degrades your cartilage and bone. With Cingal, with the HA in there, it's chondroprotective. It's safe to use for repeat injections. And it has both short and long-term pain-relieving effects. The other thing that I would highlight about Cingal is this clinical data is unparalleled. We see over 70% pain relief at six months.
These are very difficult studies to get to those types of endpoints and even demonstrate superiority to placebo, which we do hands down. But we also see an over a 90% responder rate, which I don't know of another pain product that has a responder rate that's that high. It's really the clinical data that's been driving that double-digit growth outside the United States. It works. It's incredibly pain-relieving. And people typically come back at about the six- to nine-month time point for their next injection. So Cingal has been a strong double-digit grower for us outside the United States. And bringing it to the United States, we think really adds that billion-dollar TAM because it's not going to cannibalize Monovisc. Thank you.
I think we have time for maybe one more question if anyone from the audience has one.
If not, I think you showed us a little bit of a snapshot of what you're expecting to achieve here in the next few years. Can you maybe talk about some of the assumptions that you have baked in to get to those targets that you've showed us?
Yeah. And I apologize. I failed to introduce our CFO, Steve Griffin, who's sitting up here with me. I'm so excited to talk. I just dove right in. So Steve is up here. I'm going to let him take that one. Sure. I think the easiest way to break it down is to look at the OEM channel and the commercial channel. On the OEM side of our business, we have it built in that the single injection market will continue to grow in the U.S. modestly.
It'll be offset by modest price declines such that it's sort of a flattish total market. So that's built into our assumptions. It's pretty in line with the historic trends as well. Then on the commercial side of our business, we have the continued growth of our international business. Cheryl highlighted it earlier. Our commercial channel has grown on a CAGR of three years at 17%. We have a more modest expectation built into our international viscosupplement sales, just knowing that we've had a really strong performance the last couple of years. Then on the regenerative products, which fit within the commercial side of our business, it has the assumption that we're going to continue to ramp on Integrity throughout the course of this year.
Over the longer term, we see the Integrity product continuing to take share, but certainly we have a modest expectation relative to some of the larger competitors in that space. On the regen side as well, we have expectations of the first elements of revenue for our Hyalofast product beginning in the fourth quarter of 2026, really ramping in 2027. We have not included Cingal in our forecast, just given some of the dynamics associated with the FDA timing. When we get certainty around that pathway, we'll be able to provide an update on when that revenue contribution takes hold. So those are the revenue forecasts that are built into our construct. What's assumed from a profitability standpoint is that we are going to launch Hyalofast through our own commercial channel.
Because of that, we have made significant investments for the commercial expansion of our teams, so much so that in 2025 and in 2026, when we look at our regenerative solutions business and sort of model it out, we think of it as probably a drag on EBITDA, about $14 million, primarily for the continued investments in the sales and marketing team and the completion of the clinical trial and R&D work to expand the product portfolio. Then when we get out into 2027, a bit more stabilization of that such that it's less of a drag on the business. That's when you really start to see the overall profitability inflect higher when we're able to ramp the revenue on those products. Thank you.
Thank you all for tuning into the session. Thank you very much.