Good afternoon, everyone. Thank you for joining us at Canaccord Genuity's Musculoskeletal Conference. My name is Vivek Chandrasekar. I'm part of the healthcare banking team here at Canaccord, and I have the pleasure today to introduce Anika Therapeutics, a regenerative medicine-focused company with a portfolio of technologies for orthopedic and traumatic conditions. With me today is Cheryl Blanchard, the CEO of Anika Therapeutics. Thank you for joining us today. Before we begin, I want to remind everyone of any relevant disclosures, which will be found on the conference website or the firm website. With that out of the way, I'll pass it on to management.
Great. Thank you. It's nice to see everybody today. I've been in this industry long enough that I know a lot of people in this room, which is really nice. I'm going to talk to you about Anika Therapeutics today. We have an exciting story to tell. We've actually just gone through a strategic refresh, and that's what I'll be focusing on today. Just as a reminder for everybody, we are a public company, so here's our safe harbor statement. Anika is a company with a very exciting story, with a great opportunity for value-building potential in the next few years. We're a company that was founded many years ago on the basis of a platform of hyaluronic acid technologies.
Those are technologies that I'll be speaking about today, but really very focused on our products and our pipeline and kind of what the next few years of value-building opportunity looks like for the company. We are the global leader in osteoarthritis pain management products. We occupy the number one market share position in the United States. I would say we are very much an emerging leader in the regenerative solutions space in early intervention orthopedics. I'm going to dive into a lot of detail on what those mean relative to our products and products that are in our pipeline. We have an awful lot of value to unlock. Today, the products that we sell sell into in the United States about a $1 billion addressable market opportunity.
With products that we have in our pipeline that we'll be launching in the next couple of years, we're adding an additional $2 billion of addressable market opportunity. Today, we have our Integrity Implant System that we put into full market release last year. Very exciting product that is a regenerative implant to treat tendon augmentation and tendon repair. It's a product that's been growing 40% sequentially for us. Very exciting, a lot of benefits to that product. I'll talk a bit about it. Next up from a time perspective is Hyalofast. Hyalofast is a single-stage off-the-shelf cartilage repair product that we are in the process of filing with the FDA right now. It's a product that we sell in over 30 countries outside the United States and actually just last year had 15-year clinical data published on it.
I'll talk a bit more about Hyalofast and what that does relative to the trajectory of the company here by 2026. A little bit longer term is Cingal, our next-generation osteoarthritis pain management product that is a combination of hyaluronic acid and a steroid, triamcinolone hexacetonide. It's truly a next-generation product. I'm going to show you some clinical data on it today. We're in active dialogue with the FDA to bring that one into the U.S. We sell that in over 40 countries outside the U.S. today. We're also a company that has a very strong financial position. We have a strong balance sheet, no debt, no need to raise money to really drive the strategy forward relative to the growth part of our story.
Let me just start out by orienting you about what our technologies are and which products kind of play into which technology platform. At the very top are OA pain management products: Orthovisc, Monovisc, and Cingal. Orthovisc is our multi-injection product. Monovisc, our single-injection product. And Cingal, the combination of HA and triamcinolone hexacetonide. Orthovisc and Monovisc occupy the number one market share position in the United States today. We sell Orthovisc, Monovisc, and Cingal outside the United States, Cingal being the market leader outside the United States. Cingal and Monovisc together growing strong double digits in our OUS markets. These are our gel-based products. We manufacture all of these products in our manufacturing facility that's located just outside of Boston. All of these products have very good clinical data that backs them. They really get sold off the basis of their clinical data.
Cingal, I'll talk about in a bit, is a product that we're working to bring to the United States. I'll show you addressable markets in a minute, but that in the U.S. will add an additional billion-dollar addressable market to the markets that we sell into. If you go down the page, that's where our regenerative solutions products are. On the right is Tactoset. Tactoset is our injectable, settable bone void filler that also is on label to be used with bone marrow aspirate and to augment hardware. Very exciting product, one that we launched right before COVID and is being used largely in kind of the early intervention orthopedic and sports medicine space. The next two products to the left, Hyalofast and Integrity, leverage a technology that we call HYAFF.
It's a esterified hyaluronic acid that effectively turns the HA into a polymer, allowing you to spin fibers and make non-wovens, wovens, knitted fabrics, et cetera. Hyalofast is a non-woven, and Integrity is a knitted fabric that we combine with a bit of polyethylene terephthalate fiber, suture fiber for strength. Leveraging all of these technologies, this shows you what our products look like today, but we also continue to leverage, especially the regenerative platform, with additional products that we have in our pipeline. Let's talk about our addressable markets. I mentioned on the bottom is the billion-dollar addressable market that we play into today in the United States with Monovisc and Orthovisc. Our Integrity Implant System for tendon repair plays into about a $220 million addressable market in the U.S. today that's growing in double digits.
I'm going to talk about Integrity a bit more in a minute, but this is a product that is here and now that we're selling through our sales force in the United States and have started selling it outside the United States. Hyalofast, our single-stage cartilage repair product, sold outside the United States in over 30 countries that we are currently taking through the FDA and we expect to be selling by 2026, is going to add $1 billion to our addressable market. That is a product that we also plan on selling ourselves. Very exciting product. And then Cingal, a little bit further down the road, on top there, adds an additional $1 billion addressable market just in the United States for a next-generation osteoarthritis pain product.
We're driving toward that $3+ billion addressable market opportunity as we continue to launch these game-changing and highly differentiated products that are all leveraging our proprietary hyaluronic acid platform. Let me do a little bit of a deeper dive on our products now. This slide shows you our visco supplement products, Monovisc and Orthovisc. In the United States, you can see on the right-hand side there, we sell these products through J&J MedTech, our sales and marketing partner. They're a very strong sales and marketing partner, again, occupy the number one market position in the United States. These are great products sold off the strength of their clinical data. Outside the United States, Orthovisc, Monovisc, and Cingal represent our OA pain portfolio OUS. That is a piece of our business that we've grown strong double digits for a number of years.
We continue to see strong uptake as we drive continued geographic expansion and also see a lot of organic growth in country. Our Integrity Implant System, this is a regenerative patch material that is largely made out of the resorbable HYAFF material or the esterified hyaluronic acid. It is a knitted structure that has a bit of polyethylene terephthalate in it. It has a lot of benefits and features that we see incredible excitement around in the surgeon community right now. It is very strong. It is very strong when wet, which the first-generation collagen products that are out now are not strong when wet. They get wet, they kind of turn into tissue paper. This product, you can suture through it. It has very high suture retention strength, again, even when wet.
We've also done a head-to-head animal study comparing the regenerative properties of Integrity to the market-leading product, the market-leading collagen product that's out there today. We've seen about three times the regenerative capacity because of that HYAFF regenerative material that's in it. It's also very easy to use. It's easy to implant. We've developed fixation and instrumentation that go along with this with a very easy-to-use lateral surgical technique. This product is the one I mentioned that's been growing 40% sequentially. We expect to see continued uptake and continued growth as we sell primarily in the United States through our sales force, but we're starting to sell it OUS at the same time. Hyalofast. Hyalofast is our single-stage off-the-shelf cartilage repair product. This is 100% HYAFF. It's a non-woven, highly porous, highly regenerative biomaterial. It can be used to treat both chondral and osteochondral lesions.
Doesn't require a second surgery and will be at a price point that, while still attractive for the investment community, is not going to be what the current cartilage repair product on the market is today that sells for about $50,000-$60,000 a pop. We're very excited about Hyalofast. It's very unusual to be able to launch a product in the United States with 15-year clinical data, but that paper published last year. We are completed with enrollment on our pivotal clinical trial that we've done for the United States approval and have filed our first module for our modular PMA. We have a Breakthrough Device Designation. We actually have earnings in two days, so I'll give a bit of an update on progress on this program in a couple of days.
Again, in the United States, we think this is going to add a healthy $1 billion-plus market opportunity. I think the current products that are out there are somewhat restrictive in that one product requires two surgeries. The price point, the insurance process is fairly complex. This is a product that will have a shelf life. It will be able to sit on the shelf in an OR, in an ASC, in a hospital. I think you all know many cartilage lesions are incidental. They're not often identified with imaging pre-surgery. For the surgeon to be able to go in, be doing an ACL reconstruction, a meniscal repair, and find an incidental cartilage lesion, grab this off the shelf and repair it, I think is going to be a big deal and really open this market up a lot. We plan on launching this product by 2026.
It's a real-time line of sight for us. Cingal, our next-generation OA pain product. This is a product that has been some years in development. We are in current conversations with FDA about the remaining work that we're doing right now to bring this product to the United States. This is a really game-changing osteoarthritis pain product. What we see after having done three phase III clinical trials is very repetitive and consistent, over 70% reduction in pain out to at least six months with over a 90% OMERACT-OARSI responder rate. I haven't personally seen clinical data like this in the OA pain space. It's a tough space to really get consistent OA pain data. Across three phase III clinical trials, we have seen very consistent data for Cingal. There's only one other next-generation OA pain product on the market in the United States today.
It's the long-acting steroid Zilretta. We have put a comparison up here between our two clinical studies around the type of pain relief and, frankly, the durability of pain relief that we see is a difference between these two. We sell this product outside the United States in over 40 countries. It's the market-leading product. We know what this product does. We know what the clinical data says, and we know how much the clinicians love it who are using it. We are making progress with the FDA, and we are planning on giving further updates on this as we make progress. Very exciting, fast-acting pain relief and long-acting pain relief. It's very safe. It's a non-opioid. It's non-addictive.
Let me talk for a minute about our top line, and then I'll move on to a financial summary and then make sure I take time for questions. We came out last year and started talking a bit differently about the company. We just completed two divestitures that really have us now focusing completely on building out really game-changing products that treat both osteoarthritis pain and provide products that are regenerative to treat a number of early intervention orthopedic conditions. The two ways that we're talking about revenue are our commercial channel and our OEM channel. Anika started out as a CDMO and developed Orthovisc and Monovisc and then partnered those out to J&J MedTech. It's been a very good relationship. It continues to be. Those products are sold very well through that sales force in the United States.
Anika sells those products outside the United States, so i n the U.S., they're in our OEM channel. Outside the U.S., they're in our commercial channel. Our regenerative products, we sell in the U.S. and outside the U.S. All of our regen products are talked about as part of our commercial channel. Orthovisc and Monovisc in the U.S. are in our OEM channel, along with a couple of other products like our veterinary products. That's how this slide is divided up. Our OEM channel on the bottom. This is a very good business. It's very cash generative. The cash generation that we derive from that part of our business is really funding the growth strategy that is our regen business and Cingal in the future. That commercial strategy is really driving the light blue on the top of this slide.
You can see there that we have been growing that piece of the business nicely. We have a history of having grown it at a 17% CAGR over the last few years. You can see as we start to get to 2026, where Hyalofast comes into play, that part of the business really becomes our growth strategy going forward. We have this OEM channel, high margin, high cash generative, really funding the high growth piece of our strategy, which is largely around the regen solutions in the planning period that you see on this slide. Our commercial channel revenue is projected to be about half of our business by the time we get to 2026. We are really changing the mix of our revenue stream as we go forward. Just a quick summary on our financial highlights.
We're reporting out earnings on Wednesday, so we'll have a further update at that point in time. I would just point out here in terms of sort of mid to long-range planning, our commercial channel, as you can see there, is really projecting significant growth. That's really being fueled by now our full market release of Integrity and launching Hyalofast by 2026. Our OEM channel continues to be very profitable, high gross margin products, and gives us good cash flow to continue to fund this growth strategy. We have a very strong financial position. We are not in need of fundraising. We have a strong balance sheet. We're actually in the process of doing a share buyback, so that's part of where some of our cash is going at the same time. We will continue to provide financial updates as soon as we get past earnings.
Let me just summarize here so I leave a little bit of time for questions. This really is kind of aligned by time. Near term, we continue to deliver our market-leading OA pain management products and continue to sell those either ourselves OUS or with our sales and marketing partner in the United States, continuing to drive healthy cash flow to fund our growth strategy, which is here and now. For Integrity, that's in full market release, and we continue to see great uptake. I failed to mention with Integrity, the biggest use case for that is in the rotator cuff, and that's really where the instruments and fixation are designed to treat rotator cuff tendinopathy and tendon pathology. We are also selling into the foot and ankle, in the hip, in the knee.
It is starting to be used in other tendon repair applications simply because of its value proposition for the surgeons that it's strong and highly regenerative. That is near term. That is here and now. We're seeing that happening. Midterm, we've already begun our filing with the FDA for Hyalofast to bring that into the United States, adding an additional $1 billion addressable market opportunity. A little longer term with Cingal, we continue to make progress with FDA that will add an additional $1 billion addressable market opportunity. We're very focused on ensuring that we're focusing our investments on the highest return of invested capital and driving shareholder value with this strategy. Thank you very much. Any questions? Yes.
In regards to Cingal outside the U.S., have you noticed a lot of product cannibalization from Orthovisc and Monovisc?
It's a great question. I will do that.
The question was, outside the U.S. where we sell Cingal, Orthovisc, and Monovisc, do we see cannibalization of either Orthovisc or Monovisc with Cingal? The answer is no. And there's a very good reason for that. It's a question that we get often, and it's a very good and reasonable question to ask. The use case for Cingal is actually a bit different than for Monovisc and Orthovisc. We really don't see it cannibalize Orthovisc because that's a multi-injection product. You would expect if it was going to cannibalize anything, it would be Monovisc, but it does not. We have launched Cingal in over 40 countries where we were already selling Monovisc, and we never saw any cannibalization, in fact, continued growth of Monovisc as we grew Cingal. The reason for that is it tends to get used where a surgeon would otherwise have used a steroid.
They like Cingal instead of a steroid because of the HA, it's chondroprotective. It has really good safety data for repeat use. If there's any kind of an inflammatory process ongoing and they want to make sure they give long-term pain relief, they typically use Cingal. We do not see any cannibalization of Monovisc with Cingal. I will tell you the best market I like to talk about as an example is Canada. I think that's probably the closest to kind of how we think about the U.S. market. We started selling Cingal there years ago after having sold Monovisc, and the two continue to grow side by side. There's good data to prove that point out. Absolutely. Yes.
This is regarding Hyalofast. The cartilage replacement market is currently dominated by one player, as you showed in the slide.
What differentiates Hyalofast from the competition, and why do you think it can compete for market share?
Yeah, great question. It's really about Hyalofast, and there's one player in the U.S. today, and how will we effectively compete against them? I think with a number of ways. First of all, the market leader in the U.S. today, it's an autologous cell therapy that requires two separate surgeries. The patient has a surgery. They have a biopsy taken in a non-load-bearing part of their knee joint. The biopsy gets sent back to the company. It gets processed, cells expanded, put on a collagen matrix, sent back for a second surgery. The healthcare system and the patient have to support two separate surgeries. Hyalofast will be a single-stage product. It is a single-stage product. It will sit on the shelf. The surgeon will grab it, implant it.
It also can be used for chondral and osteochondral lesions. It has a very broad use case from a clinical indication perspective. I would also point out just the difference in price point. We obviously have not talked about what the actual price point will be in the United States. It will not be $50,000-$60,000 for the product. I think there are an awful lot of really great reasons why we feel confident that Hyalofast is going to make real headway in the United States when we get it launched. Yes.
Will Cingal be an OEM product or a commercial product?
It is a great question. Will Cingal be an OEM product or a commercial product? We have talked publicly about the fact that we have had ongoing efforts having conversations with potential distributors.
We feel like the sales channel, while there's a lot of good overlap, it's about 50% overlap, but our current sales force really plays into the surgical environment and supporting surgeries and really being in the OR with the surgeons, whereas this is an in-office injection also done by rheumatologists and general orthopods. We will most likely partner Cingal, but right now we haven't committed to anything. That's the conversation we've been having. Yes. Yeah, that's a great question. What's taking so long for Cingal to get approved? You know, a lot happened before I came to the company, so it's a piece of history that I've had to come to understand. One thing that happened was the FDA changed how they regulate hyaluronic acid. Hyaluronic acid today is regulated with 14 other products as a device.
All those products have device approvals as Class III devices through a PMA. In 2018, the FDA put out a Federal Register notice that said if you have an HA product that will treat osteoarthritis pain, you have to go to the Office of Combination Products and get a request for designation. When you do that, they say, "Now it's a drug." The company had already done clinical trials and kind of planned a strategy around how those products are currently regulated today, and the FDA changed how they think about hyaluronic acid. That is one piece of it. The other piece of it is when they said, "Now, now HA is a drug," it vastly increased the complexity of the regulatory pathway because triamcinolone hexacetonide is a drug, no argument there.
It then turned the product into a drug-drug combination product, which then requires you to meet the fixed combination rules of a drug-drug product from a clinical perspective. It just significantly lengthened the kind of clinical development pathway and has caused us to have to go back after three phase III clinical trials and do additional animal studies because the animal data that we had, the preclinical data we had, was for a device approval. There were a handful of animal studies that we unbelievably had to do after they had us do three phase III clinical trials. That is the unfortunately not short answer. I have a much longer version if you're interested. Other questions? Go ahead.
This is regarding Integrity. As you mentioned in the second slide, it appears to be rapidly gaining traction.
You cite the large stake as one of the reasons. Is there any additional details on why it's driving growth? On what is driving its growth?
Yeah. The question is really, what is driving the growth of Integrity? I mean, you point out that it's a nice market. It's a $220 million addressable market in the U.S. that is growing double digits. It's nice to be selling kind of the better mousetrap into a large and fast-growing market. I think Integrity has also been shown and understood by surgeons to bring them and their patients a pretty significant value proposition. We've got the head-to-head animal data that shows that it's about three times as regenerative as the market-leading collagen product. The fact that it is really and truly strong even when wet.
I was sitting with a surgeon the other day who happens to be a competitive bodybuilder, and she had the Integrity patch in her hand for my 20-minute conversation and did everything she could to tear it apart. She could not. She sat it down on the desk when we finished and said, "I want this." I do think the fact that for an orthopedic surgeon to feel very confident about the biomechanical construct that they end up with with their tendon repair has also been a really big deal.
I also think the fact that we developed a really slick set of instrumentation, a simple lateral-first surgical technique, these are all things no one surgeon has any one thing that is important to them, but I think we've put together a really nice slick product that not only is easy to use, is pretty quick for them to use in the OR. Foot and ankle surgeons are adopting it, again, because of the fact that it's so regenerative and it's strong. I think we're going to see a lot more excitement around this technology platform. I also talked last quarter about the fact that we're in the process of developing additional shapes, sizes, and configurations that are really tailored towards other specific tendon repair anatomies. We'll be talking more about that as we get to launching those here this year.
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