Thank you for joining us at this year's Canaccord Genuity Musculoskeletal Conference. My name is Ben Ragland, and I'm on the healthcare banking team here at Canaccord. I'm joined today by Anika, a publicly traded medical device company with a portfolio of hyaluronic acid-based technologies focused on joint preservation. With me today is Steve Griffin, CEO. Thank you for joining me. Before we begin, I want to remind everyone of any relevant disclosures, which can be found on our conference and/or firm website. With that, I'll hand it over to management. Thank you.
Great. Good morning. Thank you, everybody, for joining us. Thank you very much for the introduction. Thank you for the opportunity to tell our story. I'm Steve Griffin. I'm here representing Anika Therapeutics. Excited to talk to you a little bit about our business and our set of products. Standard set of safe harbor statements. I'll start by just talking for a moment about the investment rationale. Anika has been around for 33 years, primarily focused on hyaluronic acid. Our product set has ranged across osteoarthritis as well as regenerative medicine. We believe we've got core competencies in both, and we're excited to talk a bit about our products that are in market today, as well as our products that we expect to bring market in the future.
Our strategy has evolved over the last couple of years, and we continue to focus on driving top-line growth. Our highest growth comes from our commercial channel, while we continue to have a very strong relationship with our OEM channel, which represents an important aspect of our business. We have a few important products that we continue to drive value through. I'll talk a bit about them individually here today. For our core business, we generate strong profitability, strong cash flow, which makes this an interesting opportunity for investors alike. When we look at the business in total, we have a strong balance sheet, over $50 million in cash and no debt. In 2025, we just announced our results last week, generating positive EBITDA and positive free cash flow.
When we separate out our products, we split them between our OA pain management portfolio, which is made up of Orthovisc, Monovisc, and Cingal. These are visco injection products that are used primarily to treat osteoarthritis pain in the knee, as well as our Regenerative Solutions portfolio, which is primarily made up of Integrity and Hyalofast. Our visco injection portfolio is sold, these three products globally. In the United States, we sell Orthovisc and Monovisc. We have over 30 years of developing these and represent a market leadership position, which I'll talk further about. In the Regenerative Solutions portfolio, we've had Hyalofast in market outside the United States for over 15 years for cartilage repair. In the United States, we launched Integrity in 2023, which is a tendon augmentation product.
Both products formed on the basis of our HYAFF technology, which is a bioabsorbable esterified hyaluronic acid biopolymer that we can use to shape both the Integrity patch as well as Hyalofast. When we look at the total opportunity set that exists for our business, we look at a TAM of about $3 billion-plus. I'll first start by talking about Monovisc and Orthovisc, which you see on the bottom here is representing over $1 billion in TAM. These are sold today in the United States combined through Johnson & Johnson with a market-leading position, as I referenced before, for osteoarthritis pain. The second up from the bottom is the Integrity Implant System. The Integrity tendon augmentation patch for us operates in about a $230 million space here in the United States alone.
Good growth for us, one that we believe we are differentiated. I'll talk a bit more about that in subsequent slides. Hyalofast represents part of our product pipeline. It's sold outside the United States in over 35 countries, and we've submitted a PMA in the United States here with the FDA to pursue what we believe is a very attractive market for us at over $1 billion. Cingal is our next generation OA pain management product, which is a combination of Monovisc as well as a steroid, which is fast-acting, which we believe will unlock another $1 billion worth of total addressable market. Let me first start by talking about our products that are sold here in the United States, our visco injection market. Our visco products today are Orthovisc and Monovisc here in the US.
We are a market leader collectively with J&J, DePuy. We've got great demonstrated capabilities of long-lasting pain relief. They're effective at over 6 months in terms of pain relief, whether it's with Monovisc, a single injection, or Orthovisc as a multi-injection product. High molecular weight, safe products that we manufacture. All of our products are manufactured in Bedford, Massachusetts. These represent an important baseline for our business. They are a core profitable piece and generate strong free cash flow. As I noted on the right-hand side, we've got a differentiated market position through our long-standing relationship with J&J, been in place now for over 10 years on both products. Outside the United States, we sell Orthovisc and Monovisc through our direct commercial channel. We partner with country-level distributors, stocking-level distributors.
We operate in over 40 countries, as I mentioned before, where we've demonstrated consistent and repeatable growth. The Integrity Implant System is a newer product in our portfolio. I referenced this before. This is the one that has about a $200 million addressable market. The Integrity tendon augmentation patch is strong, so it demonstrates strength even when wet. It's something that helps to establish a good procedure for surgeons, and it's something that we believe is differentiated relative to the collagen-based implants that are in the market today. We believe it's versatile in terms of its ability to be used arthroscopically. We've got our own set of instrumentation to support surgeons with that. And we've proven this capability with the HYAFF that we use as part of the same products for our Hyalofast product. It's easy to use.
It's actually very soft and pliable, but it also retains suture, and it also is very easy for use. This is a product that we launched in 2023. Last year in 2024, we did about $2 million in sales, and then in 2025, we did about $6 million in sales. We launched this product through our own commercial channel here in the United States. We have some limited product sales outside the United States, but our primary market here has been in the U.S. We're very pleased. It's been ahead of our initial launch expectations, and it's one that we think represents a continued growth avenue for us as our business as we diversify our revenue channel. The next product I'll hit on is Hyalofast.
Hyalofast is also a HYAFF core capability of the business and one that we believe will represent a unique opportunity for the cartilage market here in the United States. Outside the United States, we sell Hyalofast in over 35 countries. We have clinical data from outside the US for over 15 years. We've implanted over 40,000 for cartilage repair, which is, I think, a testament to the long-standing nature of this capability for the business as well as for the impact on the patient. It's a single surgery, which means it's gonna be held on the shelf, single stage. We think that is a differentiated value proposition relative to the marketplace today. We think that the capability that we've demonstrated with this product continues to create an attractive opportunity here for us in the United States.
It's a highly regenerative material. We combine it with BMAC, and as we pursue our PMA approval here in the United States, we've performed our clinical trial with BMAC for the regenerative capability of cartilage. I noted on our earnings call last week that we have completed our third module for the filing in the FDA. That was completed in the fourth quarter of last year, and we're beginning back-and-forth discussions with the FDA regarding our clinical data. We did not meet our primary endpoints, our co-primary pre-specified endpoints, but we did demonstrate statistical significance on our secondary endpoints. We believe that plus our data from outside the United States will represent an important piece of our communications with them as we seek approval here in the U.S. When we look at the U.S. market, many people know Vericel and their MACI product.
Obviously, they represent the biggest piece of the overall portfolio, and there are a few other competitors on the list as well. When we think about launching this product in the United States, we are currently planning on launching this through our commercial channel, which has demonstrated the strong growth that we just talked about Integrity on the prior slide. We'll plan to share more updates as we get further into the year. Lastly, from a product development standpoint is Cingal. Cingal is a combination of triamcinolone hexacetonide, which is a fast-acting steroid, as well as Monovisc. Monovisc is the market leader today from a single injection perspective for hyaluronic acid here in the United States. It's fast-acting. We've completed 3 phase three trials demonstrating statistical significance against the placebo, against Monovisc alone, as well as against triamcinolone hexacetonide.
We have been injecting this in over 1 million patients around the world since launch. We are working with the FDA as part of our progress to submit an NDA here in the United States. We've gone back and forth over a period of time in terms of determining what that filing pathway looks like. There were two elements that we needed to get completed before filing. The first one was a set of toxicity studies that were successfully completed in 2025. The second one is a bioequivalent study for the triamcinolone hexacetonide portion of the product for which we initiated that study at the end of last year. We will continue to progress over the course of this year.
Once we're able to complete that bioequivalent study and work through our CMC preparations, we expect to be able to file the NDA here in the United States and look forward to having discussions. We believe this represents an incredibly important channel for us to continue to grow our overall top line of the business. We sell our products through two different sides of the business. First is in our OEM channel that's represented in the dark blue here. Our OEM channel is primarily made up of our product sales in the United States for Monovisc and Orthovisc with J&J MedTech. That channel has been difficult in the last year or so, primarily related to pricing here in the United States, and you can see that is reflected in the 2025 results. We also sell our products through our commercial channel.
Our commercial channel is made up of our international OA pain distribution, as I mentioned, in over 40 countries, as well as the product sales for Hyalofast outside the U.S. Our commercial channel has demonstrated consistent value generation over the last 5 or 6 years. You'll note here that on the last 5 years, generating total top-line revenue increases of 17% per year. I think this demonstrates the product set that we have today, our ability to continue to launch in new markets without adding significant numbers of new products. We do expect to add Integrity growth outside the U.S. that will help supplement that growth here into 2026 and beyond. Our financial highlights for the business are represented here. Total top-line revenue for the business grew through 2023 and then saw a subsequent decline.
That decline was noteworthy as a result of the changes in the pricing market for the OA pain products here in the United States. We expect 2026 to see top-line growth again. As I noted on the bottom, you can see the split between the commercial channel and the OEM channel. Our commercial channel has demonstrated that strong growth that I referenced before, growing from $26 million back in 2021 up to $48 million in 2025. We expect that to grow again in the mid-teens range. Our guidance for 2026 revenue growth for our commercial channel is between 10% and 20% top-line growth.
When peeling back a layer of that top-line growth, we expect to see our international OA pain products as well as our international regenerative products continue to grow in the low double-digit range, which will drive the majority of the dollar increase. We expect to see our U.S. regen business, primarily Integrity, contribute to the largest overall variance increase year-over-year in 2026. Together, we expect that mid-teens growth rate to be something that we would be able to support longer term as well. When we plan out our further growth trajectory, we do expect that we would launch the Hyalofast product here in the United States, assuming we get FDA approval through that channel, which will help to contribute to that 2027 growth rate.
The OEM channel is primarily made up of our product sales to J&J, which are high margin, highly free cash flow generative to the business. As I noted before, the overall revenue decreased in 2025. We look towards 2026, we expect to see that business to be flat to maybe modestly lower as we expect to see continued volume increases, specifically in Monovisc, the single injection OA pain product, offset slightly by price. We look in the out years, we expect this business to be flat to modestly lower, which is, I think, in line with what the market trend has been for a product like this. We announced last week during our earnings call that we had overall generated around $5 million worth of adjusted EBITDA.
In 2025, we generated over $11 million worth of operating cash flow in the business. When we look towards 2026, we expect the adjusted EBITDA for the business to be between 5% and 10% of revenue, primarily as a result of continued top line growth, as well as some additional cost out actions that we've taken as a result of some recent leadership changes. Also slightly offset by the pricing impact for the OEM portion of our business. As I mentioned before, this is a very strong financially footed business.
We've got a strong balance sheet with over $50 million in cash and no debt, and we're able to generate significant operating cash flow, which allows us to invest into our existing manufacturing facilities, which I mentioned before are based outside of Boston. We manufacture all of our products in the U.S. I noted last week during our call the strategies that we've put in place to deliver shareholder value. I'll just briefly mention them here. First and foremost is accelerating growth on the top line, and that happens primarily through our commercial channel. The demonstrated ability to deliver 17% CAGR growth over five years, I think shows that. When we look towards this year, we're excited about that opportunity that's in place for us to continue to deliver on the international OA pain products as well as our regen products.
The second avenue for us to deliver shareholder value is our product pipeline. We believe we have a unique and differentiated product pipeline. First is in the Integrity portfolio of assets. We continue to launch new shapes and sizes in the United States, which we believe is important for us to continue to partner with clinicians to deliver the most value to patients. The second one is in regards to Hyalofast, where we've submitted our PMA and are working back and forth with the FDA. Lastly is Cingal, where we've got over 1 million injections internationally, and we expect to be able to file for an NDA here in the U.S. The third area for us to deliver shareholder value is in regards to strengthening our overall operational discipline. Operational discipline for us comes in 2 forms. First is in manufacturing.
We've got a manufacturing business where we are manufacturing products every day. Delivering productivity, so we can improve yield and throughput that allows us to improve our gross margins over time is very valuable not only to us, but also to our shareholders, and that remains a top priority for us as we continue to lean forward. Secondly, for operating discipline comes in the form of expense management. One of the things that we announced last week was a reorganization of our leadership team to better align with the existing scale of our business today and allow us to continue to scale into the future, so that as we grow our top line, we can see improved profitability and cash flow for our business. With that is the summary of the presentation. I'll open it up to questions. In the back.
Hi. The HA market is pretty mature. A rise of rivals. You spoke about investing in kind of like pipeline and structure. I was wondering about R&D, kind of phrases in a clinical context. Volume of that like hydrogels, you've got 1 that lasts 1 year that had quite an effect on surgeon practices switching away from HA. Are you looking at any R&D or development to increase the stability of HA product line?
Sure. Are there microphones that we could pass around? Just 'cause I'm worried there might be people on the phone that didn't hear the question.
Just repeat it.
Okay.
Speak up.
I think the question is in regards to R&D, our pipeline, our ability to continue to deliver R&D for HA, especially in regards to a competitive HA market. Did I hear correctly?
Yeah. Is this any easier? Can you-
There it was.
All right. Yeah. In the hydrogel segment, which has had quite an impact on some sports knee surgeons 'cause it's a one and done, lasts about a year, is shifting practice away from HA-based viscosupplementation. I was wondering, 'cause you mentioned investment in your pipeline, et cetera, in terms of the R&D investment in maybe stabilizing HA products, can you give us any information or insight as to whether or not you're putting any investment into R&D?
Sure. We are putting investment into R&D. R&D for us specifically is related. In the world of visco, it's related specifically to Cingal. Cingal, for us, we think represents the next generation of OA pain in the U.S. We've seen demonstrated results for that. We also continue to see that outside the United States, where we've been able to sell both Monovisc and Cingal in country together without cannibalizing one another. I think that we do see a continued growth in the volume growth that we've seen both in the U.S. and outside the U.S., for us furthers our reasoning for making those investments. Are there competitors in the space? Absolutely. Overall, I think we see that continued opportunity to be regarding Cingal.
I think the other side for us for R&D is more in the HYAFF side of our business, which is on Integrity, Hyalofast, and other product development ideas that we have in the pipeline that we haven't discussed. I think there are certainly, we know there are a lot of competitors in this space, but we believe we've got a differentiated set of technology that we'll continue to drive forward on.
Yeah. Thank you.
Other questions? Okay. Thank you, everybody, for your time.