Anika Therapeutics at CG 2025 Musculoskeletal Conference: Strategic Growth Unveiled

On Monday, 10 March 2025, Anika Therapeutics (NASDAQ: ANIK) presented at the CG 2025 Musculoskeletal Conference, outlining a strategic refresh focused on growth within regenerative medicine. CEO Cheryl Blanchard highlighted the company’s strong market position and future opportunities, while also acknowledging regulatory challenges. Anika is leveraging its hyaluronic acid platform to expand its reach in osteoarthritis pain management and early intervention orthopedics.

Key Takeaways

• Anika Therapeutics holds the top market share in the U.S. for osteoarthritis pain management products.
• The company plans to launch HILOFAST in the U.S. by 2026, potentially adding $1 billion to its addressable market.
• Anika maintains a strong financial position with no debt and is executing a share buyback program.
• CINGAL faces regulatory hurdles in the U.S., but Anika is actively engaging with the FDA for approval.
• The commercial channel is projected to represent half of the business by 2026, supported by the Integrity Implant System and HILOFAST.

Financial Results

• Anika operates through two revenue channels: Commercial and OEM.
• The OEM channel, driven by MONOVISC and ORTHOVISC sales in the U.S., provides substantial cash flow for growth.
• The commercial channel, focusing on regenerative products, is expected to grow significantly, reaching half of the company’s revenue by 2026.
• Anika projects substantial revenue growth with the full market release of Integrity and the launch of HILOFAST.

Operational Updates

• MONOVISC and ORTHOVISC continue to lead the U.S. market, with CINGAL performing well internationally.
• The Integrity Implant System has shown 40% sequential growth, primarily in the U.S.
• HILOFAST is in the FDA filing process, with plans for a U.S. launch by 2026.
• TactoSet is utilized in early intervention orthopedics and sports medicine.

Future Outlook

• Anika aims to drive shareholder value through high-return investments and strategic product launches.
• The company is targeting a $3 billion addressable market opportunity by 2026, with HILOFAST and CINGAL each contributing $1 billion.
• Anika is focused on expanding its market presence through new product launches, geographic expansion, and strategic partnerships.

Q&A Highlights

• CINGAL does not cannibalize MONOVISC or ORTHOVISC outside the U.S., with both products growing in markets like Canada.
• HILOFAST will compete with existing cartilage repair products in the U.S., offering a single-stage solution at a competitive price.
• Anika is considering partnerships for CINGAL commercialization, leveraging a sales channel with 50% overlap with its existing sales force.
• The Integrity Implant System’s growth is driven by its strong value proposition and ease of use.

For a deeper understanding of Anika Therapeutics’ strategic initiatives and financial performance, refer to the full conference call transcript below.

Full transcript - CG 2025 Musculoskeletal Conference:

Vivek Chandrasekhar, Part of the health care banking team, Canaccord Genuity: Good afternoon, everyone. Thank you for joining us at Canaccord Genuity’s Musculoskeletal Conference. My name is Vivek Chandrasekhar. I’m part of the health care 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 Onica Therapeutics. Thank you for joining us today. Before we begin, I wanna 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’d pass it on to management.

Cheryl Blanchard, CEO, Anika Therapeutics: 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. So I’m gonna 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. So Anika is a company with a very exciting story with a great opportunity for value building potential in the next few years. So we’re a company that was founded many years ago on the basis of a platform of hyaluronic acid technologies.

And 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. So we are the global leader in osteoarthritis pain management products. We occupy the number one market share position in The United States. And I would say we are very much an emerging leader in the regenerative solution space in early intervention orthopedics. I’m gonna 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 $1,000,000,000 addressable market opportunity. And with products that we have in our pipeline that we’ll be launching in the next couple of years, we’re adding an additional $2,000,000,000 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. So very exciting, a lot of benefits to that product. I’ll talk a bit about it. Next up from a time perspective is HILOFAST. HILOFAST 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 fifteen year clinical data published on it. I’ll talk a bit more about Hylofast and what that does relative to the trajectory of the company here by 2026. And then 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 gonna show you some clinical data on it today, and we’re in active dialogue with the FDA to bring that one into The United States.

We sell that in over 40 countries outside The United States 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. So let me just start out by orienting you about what our technologies are and which products kind of play into which

Unidentified speaker: technology platform. So at the very top are our

Cheryl Blanchard, CEO, Anika Therapeutics: OA pain management products. MONOVISC, MONOVISC and CINGAL. Orthovisk is our multi injection product, MONOVISC, our single injection product, and CINGAL, the combination of and triamcinolone hexacetonide. Orthovisk and MONOVISC occupy the number one market share position in The United States today. We sell Orthovisk, MONOVISC, and CINGAL outside The United States, CINGAL being, the market leader outside The United States.

Singal and MONAVIS 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. And all of these products are 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, and I’ll show you addressable markets in a minute. But that in The U. S. Will add an additional $1,000,000,000 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 TactoSat. TactoSat 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, Hylofast and Integrity, leverage a technology that we call HIAF. It’s a sterified hyaluronic acid that effectively turns the into a polymer, allowing you to spin fibers and make nonwovens, wovens, knitted fabrics, etcetera.

Hi LoFast is a nonwoven and Integrity is a knitted fabric that we combine with a bit of polyethylene terephthalate fiber, suture fiber for strength. So 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. So let’s talk about our addressable markets. I mentioned on the bottom is the $1,000,000,000 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 $220,000,000 addressable market in The US today that’s growing in double digits.

I’m gonna 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 $1,000,000,000 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 billion dollar addressable market just in The United States for a next generation osteoarthritis pain product.

So we’re driving toward that $3,000,000,000 plus 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. So this slide shows you our viscosupplement products, MONOVISC and ORTHOVISC. In The United States, you can see on the right hand side there, we we sell these products through J and 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, Orthovisk, Monovisk and Singal represent our OA Pain portfolio OUS. And that is a piece of our business that we’ve grown strong double digits for a number of years. And 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.

So this is a regenerative patch material that is largely made out of resorbable the resorbable high AF material or the esterified hyaluronic acid. And 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’s very strong. It’s 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.

And we’ve seen about three times the regenerative capacity because of that high AF regenerative material that’s in it. It’s also very easy to use. It’s easy to implant. And we’ve developed fixation and instrumentation that go along with this with a very easy to use lateral surgical technique. So this product is the one I mentioned that’s been growing 40% sequentially.

And 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. HYLAFAST. So HYLAFAST is our single stage off the shelf cartilage repair product. This is a % high f. It’s a nonwoven, 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 to $60,000 a pop. We’re very excited about Hi LoFast. It’s very unusual to be able to launch a product in The United States with fifteen 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. And 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 $1,000,000,000 plus market opportunity. I think the current products that are out there are somewhat restrictive and that they require 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 presurgery. So 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.

So we plan on launching this product by 2026. It’s 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 three clinical trials is very repetitive and consistent, over 70% reduction in pain out to at least six months with over a ninety percent Omeract ORSEA responder rate. I I haven’t personally seen clinical data like this in the OA pain space. It’s a it’s a tough space to really get consistent OA pain data. But across three Phase three 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. And we’ve 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. Again, 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. So we are, again, 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. So 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. So we came out last year and started talking a bit differently about the company. We just completed two divestitures that really has 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.

So the two ways that we’re talking about revenue are our commercial channel and our OEM channel. So Anika started out as a CDMO and developed Orthovisk and Monovisk and then partnered those out to J and 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 in 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. So all of our Regen products are talked about as part of our commercial channel.

Orthovisk and MONOVISC in The U. S. Are in our OEM channel along with a couple of other products like our veterinary products. So 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. And the cash generation that we derive from that part of our business is really funding the growth strategy that is our regen business and Singal in the future. And that commercial strategy is really driving the light blue on the top of this slide, and 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. And you can see as we start to get to 2026 where HiLaFast comes into play, that part of the business really becomes our growth strategy going forward.

So again, 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. So we’re really changing the mix of our revenue stream as we go forward. And then 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.

But 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 Hylofast 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. So let me just summarize here so I leave a little bit of time for questions. And this really is kind of aligned by time. So 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 and tendon pathology. But we’re also selling into the foot and ankle, in the hip, in the knee. There 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. So 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 HiLofast to bring that into The United States, adding an additional $1,000,000,000 addressable market opportunity. And then a little longer term with CINGAL, we continue to make progress with FDA that will add an additional $1,000,000,000 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.

Vivek Chandrasekhar, Part of the health care banking team, Canaccord Genuity: In regards to single, outside The U. S, have you noticed a lot of chronic cannibalization in Orthovisk and MONOVISC?

Cheryl Blanchard, CEO, Anika Therapeutics: It’s a great question. I will do that. So the question was, outside The US where we sell CINGAL, Orthovisk, and MONOVISC, do we see cannibalization of either Orthovisk or MONOVISC with CINGAL? The question. 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 gonna 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. And they like CINGAL instead of a steroid because of the it’s chondroprotective. So it has really good safety data for repeat use.

And if there’s any kind of an inflammatory process ongoing and they wanna make sure they give long term pain relief, they typically use CINGAL. But we do not see any cannibalization of MONOVISC with CINGAL. And I will tell you the 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 US market. And we started selling CINGAL there years ago after having sold Montevisk, and the two continued to grow side by side.

So there’s there’s good data to prove that point out. Absolutely.

Vivek Chandrasekhar, Part of the health care banking team, Canaccord Genuity: Yes. This is regarding TitlePass. The cartilage replacement market is gonna be dominated by one player as you showed

Unidentified speaker: in the slide. What differentiates TitlePass from the competition, and why do you

Vivek Chandrasekhar, Part of the health care banking team, Canaccord Genuity: think it can compete for market share?

Cheryl Blanchard, CEO, Anika Therapeutics: Yes. Great question. It’s really about Hi LoFast 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 the market leader in The US today, it’s an autologous cell therapy that requires two separate surgeries. So the patient has a surgery. They have a a biopsy taken in a nonload 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. So the health care system and the patient have to support two separate surgeries. HYLOFAST 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. So 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 haven’t talked about what the actual price point will be in The United States.

It will not be $50,000 to $60,000 for the product. So I think there are an awful lot of really great reasons why we feel confident that Hi LoFast is going to make real headway in The United States when we get it launched. Yes.

Vivek Chandrasekhar, Part of the health care banking team, Canaccord Genuity: Will Singal be an OEM product or a commercial product?

Cheryl Blanchard, CEO, Anika Therapeutics: It’s a great question. Will Singal be an OEM product or a commercial product? We have talked publicly about the fact that we’ve had ongoing efforts having conversations with potential distributors. We feel like the the sales channel, while there’s a lot of good overlap, there’s a 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. So we will most likely partner CINGAL.

But right now, we haven’t committed to anything. That’s the conversation we’ve been having. Yep. Yes. What’s taking so long for Singal to get approved?

Yeah. It’s a great question. What’s taking so long for Singal to get approved? You know, a lot a lot happened before I came to the company, so it’s a 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 three devices through a PMA. In 2018, the FDA put out a federal register notice that said if you have an product that will treat osteoarthritis pain, you have to go to the Office of Combination Products and get a request for designation. And when you do that, they say, now it’s a drug. So 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 is a drug, it vastly increased the complexity of the regulatory pathway because triamcinolone hexacetonide is a drug. No argument there. But 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. So it just significantly lengthened the develop kind of the clinical development pathway and has caused us to have to go back after three phase three clinical trials and do additional animal studies because the animal data that we had, the preclinical data we had was for a device approval.

And so there there were a handful of animal studies that we unbelievably had to do after they had us do three phase three clinical trials. That is the unfortunately not short answer. I have a much longer version if you’re interested. Other questions? Go ahead.

Vivek Chandrasekhar, Part of the health care banking team, Canaccord Genuity: This is regarding integrity. Uh-huh. So as you mentioned in the first in the second slide, it appears to be rapidly growing, gaining traction and 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?

Cheryl Blanchard, CEO, Anika Therapeutics: Yes. So the question is really what is driving the growth of Integrity. I mean, you point out that it’s it’s a nice market. It’s a $220,000,000 addressable market in The US that is growing double digits. So it’s nice to be selling, kind of the better mousetrap into a large and fast growing market.

But 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 twenty minute conversation and did everything she could to tear it apart. She could not.

And she set it down on the desk when we finished and said, I want this. So 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 you know, 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. So I I think we’re gonna 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 shape sizes and configurations that are really tailored towards other specific tendon repair, anatomies. And we’ll be talking more about that as we get to launching those here This presentation has now finished. Please check back shortly for the archive.

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