Anika Therapeutics Inc

NASDAQ:ANIK

Earnings Call Transcript 2023-Q1

[Operator]

Good afternoon, ladies and gentlemen, and welcome to Anika's First Quarter 2023 Earnings Conference Call. [Operator Instructions] This call is being recorded on Tuesday, May 9, 2023.

I will now turn the call over to Mr. Mark Namaroff, Vice President, Investor Relations, ESG and Corp Communications. Please go ahead.

[Mark Namaroff]

Thank you. Good afternoon, everyone. Thank you for joining us for Anika's first quarter conference call and webcast. Our Q1 earnings press release was issued after the close of the market today and is available on our Investor Relations website located at anika.com as our supplementary PowerPoint slides that we used for the discussion today.

With me on the call today are Dr. Cheryl Blanchard, President and Chief Executive Officer; and Mike Levitz, Executive Vice President, Chief Financial Officer and Treasurer. Please take a moment and open the slide presentation and refer to Slide #2.

Before we begin, please understand that certain statements made today during the call constitute forward-looking statements as defined in the Securities Exchange Act of 1934. These statements are based on our current beliefs and expectations and are subject to certain risks and uncertainties. The company's actual results could differ materially from any anticipated future results, performance or achievements. We make no obligation to update these statements should future financial data or events occur that differ from the forward-looking statements presented today. Please also see our most recent SEC filings for more information about risk factors that could affect our performance.

In addition, during the call, we may refer to several adjusted or non-GAAP financial measures, which includes adjusted gross margin, adjusted EBITDA, adjusted net income and adjusted earnings per share, which are used in addition to results presented in accordance with GAAP financial measures. We believe that non-GAAP measures provide an additional way of viewing aspects of our operation and performance. But when considered with GAAP financial measures, the reconciliation of GAAP measures, they provide an even more complete understanding of our business. The reconciliation of these adjusted non-GAAP financial measures to the most comparable GAAP measurements are available at the end of the presentation slide deck and our first quarter 2023 press release.

And now I'd like to turn the call over to our President and CEO, Dr. Cheryl Blanchard. Cheryl?

[Cheryl Blanchard, President, CEO & Director]

Thanks, Mark. Good afternoon, everyone, and thanks for joining us. Please turn to Slide 3.

We're pleased to report that Anika had a positive start to the year. While our reported revenue showed growth of 3%, the core parts of our business were up 9% in Q1 as we've seen the environment for some orthopedic elective procedures improving. Osteoarthritis Pain Management revenue was stronger than expected in the quarter and remains a market-leading business that continues to win globally.

We were excited to see double-digit growth in Joint Preservation and Restoration in the quarter, which included early traction from our recent product launches with X-Twist and RevoMotion and international growth, driven by geographic expansion and timing. Our OA Pain Business, including our sales and marketing partnership with J&J Mitek for Monovisc and Orthovisc in the U.S. continues to provide a healthy financial foundation to support the investments driving our growth strategy. In addition to our market-leading products in the U.S., we're also particularly pleased with our strong international performance as we grow market share of our OA pain products, especially Cingal as more and more clinicians and their osteoarthritis patients realize the benefits of this truly next-generation non-opioid OA pain product.

With respect to Cingal, we are actively engaging with the FDA regarding next steps for U.S. regulatory approval and exploring commercial partnerships to advance Cingal in the U.S. and select Asian markets. We're excited about our continued progress and momentum in our Joint Preservation and Restoration portfolio. We had great traffic and training opportunities at our booth at the American Academy of Orthopedic Surgeons meeting in March, with a lot of interest across our full Joint Preservation portfolio.

We're building traction and adoption as we continue to hear great feedback from surgeons following the Q1 full market release of X-Twist, Anika's cornerstone suture anchor system as we increase awareness and educate surgeons about its flexibility and surgical versatility across procedures in the shoulder and the foot and ankle.

We're receiving great early clinical feedback following the successful limited launch of our new RevoMotion reverse shoulder system, which significantly expands our shoulder arthroplasty portfolio. Patients are doing well in their early post-op visits, some now out to 4 months, and surgeons are extremely pleased with the post-op X-rays. We look forward to build momentum ahead of a full launch, which we're continuing to target towards the end of this year.

Tactoset, Anika's regenerative solution for insufficiency fractures and hardware augmentation received an additional 510(k) clearance, further building the Tactoset franchise. Tactoset is now cleared for use with autologous bone marrow aspirate, a key component in regenerative healing.

I'm also happy to welcome Gary Fischetti, who is appointed as a new independent director in April. Gary brings decades of relevant experience in the medical device industry, including more than 35 years at Johnson & Johnson with both domestic and international leadership responsibilities. And we look forward to leveraging his expertise as we advance our strategy and capture the significant opportunities ahead.

Now moving on to Slide 4. Over the past 3 years, we've been investing with purpose to fundamentally reposition Anika to be a global leader in joint preservation with a focus on early intervention orthopedics, leveraging our core expertise in hyaluronic acid and our design heritage of early intervention bone-sparing devices. Our efforts have successfully expanded Anika's market opportunity from $1 billion to more than $8 billion today and created a powerful growth engine for years to come as we remain focused on launching new products in the high opportunity spaces and faster-growing segments within orthopedics.

The first update is for Tactoset. As a reminder, Tactoset is an important franchise we're building and a product we continue to get great clinical feedback on. We're now in the process of launching the new indication for use with bone marrow aspirate as we continue to expand our portfolio for regenerative healing with an additional 510(k) planned.

Moving on to X-Twist. Now that we're in full market release, we are also developing a biocomposite version as we continue to expand on our differentiated suture anchor platform. As we announced last quarter, we've developed a new hyaluronic acid-based arthroscopic regenerative rotator cuff patch system which will further strengthen Anika's growing and differentiated shoulder portfolio.

We've initially designed the patch for the shoulder to provide augmentation to the tendon to support healing for rotator cuff tears. Anika's patch is mechanically stronger and further improves regenerative capacity compared with the first-generation collagen patches on the market. We completed multiple 510(k) submissions at the end of 2022 ahead of a planned launch next year. We'll share additional details about the product once the entire system has been cleared, and we're gearing up for first surgeries.

In short, we believe our regenerative patch will be a game changer for patients and Anika as it helps complete an innovative and highly differentiated shoulder portfolio. We are also advancing our longer-term opportunities, which will further augment and reinforce Anika's growth once they're available in the U.S.

In addition to our active engagement with the FDA regarding next steps for Cingal approval, which we believe could potentially double our $1 billion addressable market in OA Pain, we're working to enroll the final subject in the pivotal Phase III clinical trial for HYALOFAST, our highly differentiated single-stage off-the-shelf cartilage repair product.

Last quarter, we announced that HYALOFAST was designated as a breakthrough device by the FDA, allowing for prioritized interaction and review to enable patients faster access to new therapies. We remain on track to file a PMA for HYALOFAST in 2025. And given its differentiation as a single-stage off-the-shelf solution, we believe that HYALOFAST has significant market-expanding potential.

As you can see on Slide 5, we're focused on building a robust and differentiated shoulder portfolio by providing solutions for the full spectrum of rotator cuff pathologies that brings a unique value proposition to surgeons across the ASC and hospital settings. This positions Anika for continued growth as we capitalize on the approximately $2 billion market opportunity across the shoulder continuum of care. Prevalence and progression of rotator cuff disease needs multiple strategies and solutions, which Anika is addressing through our comprehensive portfolio of products across sports medicine, regenerative solutions and Arthrosurface joint solutions.

RevoMotion is a highly differentiated reverse shoulder system that now gives Anika access to the full shoulder replacement market with a focus on a bone-sparing design and a streamlined 2-instrument tray system. The launch of RevoMotion has dramatically enhanced the opportunity to drive our Arthrosurface Joint Solutions products specifically OVOMotion and Inlay Glenoid, our total shoulder system.

In sports medicine, our X-Twist design facilitates soft tissue repairs that other systems are unable to accommodate. We're adding new surgeon accounts and surgery centers as the product gains acceptance and we drive deeper penetration into those accounts.

On the regenerative side, we offer the innovative solution of Tactoset to augment hardware, specifically with suture anchors when surgeons encounter poor quality bone. This provides a truly meaningful solution to achieve a strong repair. With the recent launch of X-Twist, we now have the opportunity to cross-sell Tactoset for augmentation, providing an additional growth driver as Anika products are used in more rotator cuff procedures.

Finally, as we look to its planned launch in 2024, our HA-based arthroscopic regenerative rotator cuff patch system provides a strong foundation in regeneration alongside Tactoset. Given the attractive market for regenerative patches, we believe this arthroscopic system has expansion opportunities beyond the shoulder and will also be a key driver for growth.

With that overview, I will now turn it over to Mike for a review of our first quarter 2023 financial performance. Mike?

[Michael Levitz, Executive VP, CFO & Treasurer]

Thank you, Cheryl. Please turn to Slide 6. I will now walk you through our financial results for the first quarter of 2023. .

I'd like to remind everyone that beginning in the first quarter, veterinary sales historically reported within OA Pain Management are now included in the non-orthopedic product family for all periods presented.

Total revenue for the quarter was $37.9 million, an increase of 3% over the prior year as continued growth in OA Pain Management and accelerated double-digit growth in Joint Preservation and Restoration were partially offset by lower ancillary nonorthopedic revenues. The lower nonorthopedic revenues reduced total company growth in the quarter by approximately 6 percentage points.

Revenue in our largest product family, OA Pain Management, increased 8% to $22.6 million due primarily to favorable ordering patterns from J&J Mitek and sales growth on increasing customer demand. As a reminder, revenues can vary significantly on a quarterly basis based on ordering patterns by our partner in the U.S. and distributors internationally. However, that quarterly volatility generally stabilizes on an annual basis.

Our Joint Preservation and Restoration revenue in the quarter increased 11% to $13.5 million on growth from our new products as well as geographic expansion and favorable order timing internationally. Our nonorthopedic revenue declined 49% to $1.8 million primarily reflecting unfavorable order timing by our veterinary distributor as well as our exit from legacy product lines that do not support our growth and profitability objectives.

Our gross margin in the first quarter was 60% and includes the impact of $1.6 million of noncash acquisition-related expense amortization from the 2020 acquisitions of Arthrosurface and Parcus Medical. Our adjusted gross margin, which excludes the acquisition-related amortization, was 64% in the quarter, in line with the same quarter last year.

From a spending standpoint, our operating expenses totaled $35.4 million in the first quarter, up from $25.4 million in the same period of 2022. Our operating expenses in the quarter included $5.8 million of nonrecurring corporate costs, including a charge for $3.25 million related to our arbitration settlement in April to close any further claims from the 2020 acquisition of Parcus Medical; $800,000 of costs related to shareholder activism, which was also resolved in April as well as $1.7 million of other nonrecurring corporate costs. Apart from these nonrecurring costs, our operating expense growth in the quarter reflects increased cost to comply with expanded global regulatory requirements and investments in operational capabilities to support our sustainable growth, the majority of which are associated with our OA Pain Management and other legacy products as well as new product development and expanded marketing in support of key product launches.

Our net loss for the quarter was $10.4 million or $0.71 per share compared to net loss of $2.9 million or $0.20 per share in the first quarter of last year. Our adjusted net loss was $5.3 million or $0.36 per share compared to our adjusted net loss of $1.6 million or $0.11 per share in the prior year. Again, our lower bottom line reflects the impact of the significant nonrecurring expenses incurred in the quarter as well as the increased spending to support the continued sustainable growth of our legacy product lines as well as our growth acceleration initiatives.

Our adjusted EBITDA in the quarter was a negative $1.2 million, down from adjusted EBITDA generated of $2.6 million in the first quarter of last year. The decrease in adjusted EBITDA was primarily due to $1.7 million of nonrecurring corporate costs, as well as the cost to comply with expanded global regulatory requirements and expansion of our operational capabilities to support our continued growth.

Lastly, with regards to our cash flow and capital structure. Anika's balance sheet remains strong with $79.7 million in cash and no outstanding debt as of March 31. We had operating cash outflows of $3.6 million during the first quarter compared to outflows of $1.9 million in the prior year period. And our capital expenditures in the quarter totaled $1.4 million, up slightly from $1.3 million last year, reflecting investments in support of our new product launches and overall business growth.

We also recently announced that in April, our Board of Directors authorized a new stock repurchase program of $20 million, with the first $10 million split between an accelerated stock repurchase program and an open market program and the second $10 million through an open market program subject to positive cash flows.

Please turn to Slide 7. Now I'd like to review our full year financial outlook for fiscal year 2023. Based on our progress to date, we are reiterating our full year 2023 total company revenue outlook of $158 million to $163 million, representing growth of 1% to 4% compared to 2022 and reiterating our outlook by product family as continued growth in OA Pain Management and accelerated double-digit growth in Joint Preservation and Restoration are partially offset by lower ancillary nonorthopedic revenues. The lower nonorthopedic revenues reduced total company growth by approximately 3 to 4 percentage points.

In OA Pain Management, we expect revenue of $93.5 million to $96 million, up 2% to 4% over 2022 as our market-leading products continue to gain adoption globally, but also reflects favorable international timing last year from a comparative standpoint.

With the timing of multiple product launches this year in Joint Preservation and Restoration, we expect full year 2023 revenue growth to accelerate to $55.5 million to $58 million, up 10% to 15% over last year, with that growth weighted more towards the second half of the year. We expect nonorthopedic revenue to decrease approximately 35% to $9 million as we anniversary out of revenues in the prior year from last time buys of legacy products we exited and reflecting order timing in veterinary sales last year.

With regard to gross margin, we continue to expect adjusted gross margin for the year to be roughly in line with last year's gross margin as we remain focused on driving margin expansion, but also anticipate the ongoing headwinds from the global trends in supply chain and staffing challenges will likely continue.

With regards to spending, while spending will be higher in the first half of the year due to a number of nonrecurring situations such as the Parcus Medical arbitration and shareholder activism, now that we have settled both of those in the second quarter, we expect operating expenses to normalize in the second half of 2023. We continue to expect operating expenses for fiscal 2023 to increase over 2022 as a percentage of revenue as we self-fund our growth strategy, including both the cost to comply with expanded regulations globally and investments in operational capabilities, the majority of which are associated with our OA Pain Management and legacy products as well as our product development and launch initiatives to drive accelerated growth.

We continue to expect our adjusted EBITDA margin for the year to be in the low single digits and capital expenditures to increase in 2023 above historic depreciation to support the rollout of key new product introductions and equipment to support our legacy business. Our team remains focused on both Anika's mission to restore active living and on driving value creation for our stakeholders, and we look forward to updating you on our continued execution of this strategy.

I will now turn the call back over to Cheryl.

[Cheryl Blanchard, President, CEO & Director]

Thanks, Mike. Please turn to Slide 8. Before we open the call up for Q&A, I want to reiterate our excitement for the coming year. As our first quarter results demonstrate, we're just starting to realize the significant potential of our comprehensive and expanding portfolio. Our targeted investments have helped us build a uniquely focused joint preservation portfolio across the continuum of care and regenerative solutions, sports medicine and Arthrosurface joint solutions. Anika is well positioned to continue to execute on our growth strategy with multiple near-term value drivers, including the full market release of X-Twist now underway and of RevoMotion later this year, and the launch of our HA-based arthroscopic regenerative rotator cuff patch system in 2024. And finally, we have a healthy balance sheet with a solid cash position and no debt, positioning Anika to drive significant shareholder value. .

I would like to take a moment to thank all of our employees for their continued hard work and dedication to supporting our efforts. We're building momentum as we work to achieve our mission of restoring active living for people around the world.

And with that, we'll open up the line for questions.

[Operator]

[Operator Instructions] Your first question comes from the line of George Sellers from Stephens, Inc.

[Harrison Parsons, Stephens]

This is Harrison on for George. I wanted to start by asking you about what you're seeing in terms of procedures moving to the ASC specifically in terms of the reverse shoulder. I know the RevoMotion was designed with the ASC in mind. So what kind of impact are you seeing from that dynamic now while still in the limited market release? I mean how do you see that market moving longer term?

[Cheryl Blanchard, President, CEO & Director]

Thanks for the question, Harrison. It's a great question. And we did design RevoMotion with the ASC in mind. We are in our limited release, we are seeing procedures done in the ASC and the hospital setting. And the majority of that market, those procedures are still done in the hospital setting just because of the current situation with reimbursement from CMS.

But the patients that qualify and the payers that are inclined in that direction will support those procedures being done in the ASC. So for our limited release surgeons, whatever their respective share of patients that they do in the ASC, we are seeing it being used there with really great feedback. And the feedback in general on that system has been very positive.

I mentioned in my prepared remarks that we're seeing really great X-rays coming back from the surgeons. The surgeons are reporting that their patients are doing very well. Many of them out to 4 months at this point in time. And that the system is working very well in both the hospital and the ASC setting. So we look forward to continue to serving both of those call points with the opportunity for our system to really have uptake in that ASC because of the way it was designed.

[Harrison Parsons, Stephens]

Yes. That's great. Sounds good. I had another question on Tactoset, the additional 510(k) clearance. I was wondering how we should think about that market opportunity? I know you've tagged Tactoset as a $100 million-plus market. Is that additional clearance going to be incremental to that $100,000 -- or sorry, $100 million market? Or is that just kind of filling out the market?

[Cheryl Blanchard, President, CEO & Director]

Yes. We really felt like bringing that bone marrow aspirate indication to Tactoset was still targeting that $100 million market and was an important part as we continue to build out that franchise. So I would think of that market opportunity really bringing that additional 510(k) clearance to fill out that full market of $100 million.

[Operator]

And your next question comes from the line of Mike Petusky from Barrington Research.

[Michael Petusky]

Yes, a couple of questions. Mike, on the R&D expense, when you refer to the global requirements, I'm assuming, is that an MDR or is there something else there that's driving incremental costs? And can you just speak to sort of what's the new normal in terms of R&D expense going forward?

[Michael Levitz, Executive VP, CFO & Treasurer]

Mike, yes, you're absolutely right. The increased regulatory requirements are largely associated with MDR in Europe, but they're not limited to that. So we had in the quarter, about $800,000 of external spend alone related to MDR. We think it's going to be probably $3 million to $4 million for the full year because there is a bolus of costs associated with getting all of those filings in and all the associated testing and work to support those filings.

So it is definitely an incremental spend, and it's something that we would expect will come down over time as we get through this because a lot of that spend, the majority of that spend is related to our legacy products where we sell those in Europe and globally. But it's not just limited to MDR. So when we think about the incremental cost, there's the external cost associated with MDR, and then there's the internal costs to support all of that extra work, the complexities associated with that.

And what we're seeing is the same discussions that you're hearing on the MDR side, you're seeing expanded global requirements. We're seeing expansion globally in our business, both in visco and in sports med, so between joint preservation and OA pain management. As we enter in these different countries, there's just more work and more complexity. So we've got the external costs associated with the MDR and then we've got the work internally supporting those. And those are the things that are driving the R&D cost up.

[Michael Petusky]

So I mean $8.5 million, $9 million a quarter. I mean is that where we sort of -- sort of peg this going forward? Or I mean, can you just speak to that?

[Michael Levitz, Executive VP, CFO & Treasurer]

Yes. As I said, there's about -- so as I said, there's about $800,000 this quarter related to MDR. And I think it's going to go up and down on a quarterly basis depending on the work. I do expect it's going to be $3 million to $4 million of cost which is probably maybe $2 million or so higher than last year if you want to look at it from a run rate basis.

And then there's the -- as I said, the incremental costs associated with all the internal teamwork to manage all these different efforts. So -- we haven't given guidance specifically for the line items within OpEx. But I did reiterate our guidance expectation from a total EBITDA standpoint. So nothing has changed as it relates to our expectations for the year.

[Michael Petusky]

Okay. And then I guess on Cingal, Cheryl, the conversation with the FDA, and I don't know how active these are. But I mean, when would you expect some road map as far as, hey, this is what you need to do or don't need to do sort of to move this forward down the track. I mean when do you think you'll have a sort of a sight line towards what you need to do?

[Cheryl Blanchard, President, CEO & Director]

Yes. Great question. And we are actively engaging with FDA right now. It is difficult to predict timing in some cases with active interactions with the FDA. But I would tell you that those engagements are actively occurring. And I would look forward to being able to give an update to you all as soon as possible.

[Michael Petusky]

Can I just ask you -- and I understand speculation, but I mean, do you think by the timing of the next conference call, you'd likely have a path forward? Or do you think it could drag throughout -- longer into the year?

[Cheryl Blanchard, President, CEO & Director]

Yes. I don't know that it's healthy for any of us for me to speculate on timing. Like I said, we are actively engaging with them. And I -- as soon as I have an update, I will provide it.

[Michael Petusky]

Would that be the kind of update that would wait until the conference -- quarterly conference call? Or would that actually be a press release?

[Cheryl Blanchard, President, CEO & Director]

Not necessarily. It could be a press release. It could be an update that I give at a future investor conference. It just kind of depends on the timing of it and the content of it. But it doesn't necessarily have to wait until the next conference call.

[Michael Petusky]

All right. And then I was just wondering -- and this may also be tough to provide. But obviously, love to hear any further commentary around the X-Twist. I know it's very early innings, probably the top of the first inning. But I mean anything you can say around number of docs that have tried the product, reorder rates? I mean any -- anything you can share there even anecdotally as far as what getting traction means?

[Cheryl Blanchard, President, CEO & Director]

Yes. I mean, I guess what I would say is we are -- we really are building traction and adoption. We've done a lot of training. We are starting to see additional kind of depth in accounts with additional surgeons and ASCs that are beginning to use it. .

It's still early days. We're a quarter into the full release. So that's why we're not providing like specific numbers at this point in time. But we are really getting a lot of very positive feedback on the product itself, and we are seeing really nice traction once adoption occurs within a given account. So I look forward to giving additional metrics on that going forward once we have a bit more of experience under our belt. We're just now one quarter into a full market release.

[Michael Petusky]

So -- and then just last question on the -- obviously, balance sheet remains pristine. Are you guys seeing any interesting assets? Are you being shown things? What's the valuations? I mean, what -- is there anything you can sort of talk about there?

[Cheryl Blanchard, President, CEO & Director]

Yes. We continue to look at opportunities that we think are on strategy for us. We feel like there are things that we will continue to look at, valuations remain high. And I've seen other CEOs make the same comment in the last couple of weeks with earnings calls.

And at the same time, I think we have a pretty significant pipeline that we've developed that we're pretty focused on driving commercially right now. And I'm always balancing distraction with what we've got right in front of us. So we'll stay focused on what we've got coming into the market right now and continue to look at things that might be available out there from an inorganic perspective.

[Operator]

And your next question comes from the line of Jim Sidoti from Sidoti.

[Jim Sidoti, Sidoti]

The settlement you made with the -- related to Parcus and the shareholders too, those were both completed in April. So I was surprised to see that they were on the March quarter income statement. Why was that?

[Mark Namaroff]

Jim, we will see costs associated with both of those in the first quarter and in the second quarter because you're absolutely right, they were both resolved in April. For the arbitration settlement, that was an ongoing contingency. And under GAAP, you would record that in the current open period. And so we recorded a settlement there of $3.25 million in the first quarter. .

And we've broken that out separately and are excluding that from a non-GAAP basis. Also, in the first quarter, we had our own legal costs associated with Parcus arbitration and otherwise. And so we've kind of taken that amongst other related nonrecurring costs and call that out as $1.7 million in the quarter and not related to those legal costs and others that we believe to be nonrecurring.

So you've got that. And then we also incurred $800,000 of costs associated with the activist matter. That was costs incurred in the first quarter. We will have -- we estimate another maybe $2.5 million of nonrecurring costs in the second quarter. And that would include on the activist side, our cost as well as the cost that we are going to cover under the cooperation agreement that were incurred by the activists.

And then we also have the costs that we -- our internal legal costs associated with the Parcus arbitration matter in the beginning of this quarter. So -- we've called them out as nonrecurring. We've got $5.8 million of those in the quarter, as I said, another $2.5 million in the second quarter. And we've broken out the settlement and the activist matter as non-GAAP adjustments. The ongoing legal costs, they've been in our run rate and haven't been material enough to call out before. We're calling them out now. Those are not excluded for non-GAAP because we're treating those consistent with how we've treated them before. But we wanted you to understand they were elevated in the quarter and that's why we called them out as nonrecurring.

[Jim Sidoti, Sidoti]

Okay. I got it. Now do you think you'll have an additional charge in the second quarter for Parcus as well?

[Michael Levitz, Executive VP, CFO & Treasurer]

Yes, that was included in what I was just describing. So I think there's $2.5 million. Again, this is our legal fee, how all the costs come in. But $2.5 million all in of nonrecurring costs. And I would say, a small amount of that is the finishing up of the Parcus arbitration from our internal spend.

[Jim Sidoti, Sidoti]

Got it. Got it. Okay. Now with regards to the rotator cuff patch. I think you filed to that last year. Are -- do you have the approvals to launch that at this point? Or is there still regulatory work to be done for that?

[Cheryl Blanchard, President, CEO & Director]

Jim, yes, there were multiple 510(k)s that we filed. This is a -- it is a regenerative patch based on hyaluronic acid and also other elements of a full system. So that's why there are multiple 510(k)s. We are not announcing kind of the parts and pieces as they come along, but we will provide a more fulsome update once we have everything fully cleared through the FDA.

And because one element of that is a regenerative patch, that tends to take longer from a time frame perspective relative to how you might think about normal turnaround time for 510(k)s. If there's an element to it that's regenerative in nature, they tend to take longer.

So the timelines that we've provided, we still feel good about. And there -- that's what's in the update that we have communicated. And as soon as we have anything more fulsome to announce, we will do so. We'll look forward to that.

We're very excited about the system. We think it really completes the full continuum of care on the rotator cuff side, and we see an awful lot of advantages of this system relative to the first-generation collagen patches that are in the market today. So we look forward to updating you further on that.

[Jim Sidoti, Sidoti]

Okay. And then with regards to HYALOFAST, I think you said you had 1 more patient to complete the enrollment. And I assume it's a 12-month follow-up on that. And then I guess you're giving yourselves time to submit the PMA and then to work with the FDA. Is that why you have a 2025 estimate for that?

[Cheryl Blanchard, President, CEO & Director]

Yes. So you're correct. We have 1 more patient to enroll, and we'll be as excited as anybody when we get that study fully enrolled. The team is working hard on that. That has a 2-year follow-up, which is why the PMA filing is 2025. So that will be the clinical module of that will be the last module filed. But we're still on track to file that in 2025. And as soon as we have the final enrollment to announce, we will do so.

[Jim Sidoti, Sidoti]

Okay. So if you file in 2025, I would think back and forth with the FDA, you anticipate a launch sometime in 2026.

[Cheryl Blanchard, President, CEO & Director]

Yes. We haven't provided guidance on launch timing until we get a little closer. But suffice it to say that we'll get everything filed in 2025.

[Jim Sidoti, Sidoti]

Okay. And then the last one for me. On Cingal, it sounds like you're pursuing strategic agreements. Would they be structured similar to the agreements you have in place now for your OA Pain Management products. Would you have milestone payments attached to that? Or would that just be a straight distribution agreement?

[Cheryl Blanchard, President, CEO & Director]

Yes. I think you can think about especially the ones in select Asian markets to look more like kind of a biotech pharma type arrangement in terms of structure. And in terms of the one in the U.S., we haven't really talked much about how those would be structured. But the select Asian market type agreements are probably more how you would think about a strategic relationship that has structured payments in addition to supplying product.

[Operator]

Thank you. There are no further questions at this time. And that does conclude our conference for today. Thank you for participating. You may now disconnect.