Good morning, ladies and gentlemen, and welcome to Anika's second quarter earnings conference call. I will now turn the call over to Matt Hall, Director, Corporate Development and Investor Relations. Please proceed.

Thank you. Good morning, and thank you for joining us for Anika's Second Quarter 2025 Conference Call and Webcast. I'm Matt Hall, Anika's Director of Corporate Development and Investor Relations. Our earnings press release was issued earlier this morning and is available on our Investor Relations website located at www.anika.com along with the supplementary PowerPoint slides that will be used for the discussion today. With me on the call are Dr. Cheryl Blanchard, President and Chief Executive Officer; and Steve Griffin, Executive Vice President, Chief Financial Officer, and Chief Operating Officer, who will present our second quarter 2025 financial results and business highlights. Before we begin, please understand that certain statements made during the call today 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 may include adjusted EBITDA, adjusted net income from continuing operations, and adjusted earnings per share from continuing operations, 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 operations and performance. But when considered with GAAP financial measures and the reconciliation of GAAP measures, they provide an even more complete understanding of our business. A reconciliation of these adjusted non-GAAP financial results to the most comparable GAAP measurements is available at the end of the presentation slide deck and our second quarter 2025 press release. And now I'd like to turn the call over to our President and CEO, Dr. Cheryl Blanchard.

Thanks, Matt. Good morning, everyone, and thank you for joining us today to discuss Anika's second quarter 2025 results. Please turn to Slide 3. This has been a meaningful quarter for Anika, including a significant clinical update on Hyalofast. I'll begin today's remarks with that important development. But before I dive in, I want to note that our quarterly performance was in line with expectations, and we remain on track to deliver our full year 2025 guidance. Earlier today, we shared an important announcement on the top line results from our U.S. pivotal Phase III Hyalofast clinical trial. This study, which enrolled its first patient in 2015, is a randomized controlled trial comparing Hyalofast in combination with autologous bone marrow aspirate concentrate, also called BMAC, to an active comparator serving as the control arm, a surgical technique called microfracture, in the treatment of articular cartilage defects. Superiority between the groups was to be determined with two pre-specified co-primary endpoints: percent change from baseline to 2 years in both KOOS Pain and IKDC Function. While Hyalofast demonstrated consistent improvements in treated patients across all measures of pain and function relative to microfracture, we're disappointed that the study missed achieving statistical significance on its pre-specified co-primary endpoints under the original statistical framework. Given the consistently demonstrated improvements over microfracture in this trial and the efficacy of Hyalofast demonstrated in numerous independent studies outside the U.S., we believe these results reflect limitations in the study context rather than the performance of Hyalofast itself. Importantly, we remain highly encouraged by the totality of evidence supporting the product, which I will discuss. As a reminder, Hyalofast has successfully treated more than 35,000 patients in over 35 countries since its launch in 2009 outside the U.S. Let me take a moment to dive into more detail on the study results. The trial required randomization to microfracture, which was considered the standard of care when the study was initiated. Microfracture served as the active comparator; however, over the 10 years of trial enrollment, its broad use by surgeons declined significantly, and it is no longer regarded as the standard of care for cartilage lesions in most countries, including the U.S. The study was likely impacted by both a higher subject dropout rate in the microfracture arm and missed visits during COVID, both resulting in missing data. This missing data resulted in a reduced evaluable sample size and complicated the statistical analysis. In accordance with FDA guidelines, Anika statistically imputed missing data, which did not treat withdrawals from the microfracture arm as treatment failures. To be clear, Hyalofast demonstrated improvements over microfracture, but the study did not achieve statistical significance in the co-primary endpoints. Importantly, we did achieve statistical significance on several key secondary endpoints and other measures including KOOS Sports and Recreation Function, KOOS Quality of Life, and Total KOOS, all of which have served as the basis for FDA approval of the other cartilage repair products available in the U.S. In addition, because Anika has sold Hyalofast outside the U.S. for over 15 years, we have a significant amount of clinical data from a number of independent international clinical studies including a paper published last year with positive 15-year outcomes. We believe the totality of the data, including hitting significance on endpoints used for prior FDA approvals, statistically significant responder analyses, and multiple independent international studies strongly supports the clinical value of Hyalofast as a single-stage off-the-shelf cartilage repair solution. This is especially compelling when compared to the current U.S. standard of care that requires two separate surgical procedures. Based on these results, we plan to submit the third and final PMA module on our original schedule in the second half of this year after data analysis has been completed. Once the data analysis is complete, we will provide further disclosure of the data. This submission will include post-stock analyses and additional endpoints that achieved statistical significance in this study that have previously been accepted by the FDA and other approvals in addition to the robust international data. We remain confident in the strength of our data and look forward to working closely with the agency as they review our application through the Breakthrough Devices program. In anticipation of upcoming discussions with the FDA, we are extending our commercial timeline to 2027 to ensure adequate time for a thorough review and dialogue regarding the full data package. Hyalofast continues to represent a significant opportunity for Anika to expand our leadership in regenerative solutions and deliver meaningful innovation to patients suffering from cartilage lesions. Turning to Cingal, I am pleased to announce that we made meaningful progress during the quarter advancing the final steps toward NDA filing and remaining on track to initiate the bioequivalence study by year-end. As a reminder, this bioequivalence study and the toxicity studies initiated earlier this year address the final requirements before submission. We plan to provide an update on the Cingal program timing after we start the bioequivalence study. Next, I'd like to provide an update on Integrity. I'm pleased to share that Integrity has already exceeded its full year 2024 performance and is currently on track to more than double in 2025, ahead of original expectations, and Integrity led to 41% growth in Regenerative Solutions revenue this quarter. This exceptional growth reflects our early positive clinical data, strong market momentum, and increasing adoption across a broader base of surgeons. What's particularly encouraging is that surgeons are not only using Integrity more frequently, but also expanding its application across a wider range of tendon repair procedures. While the shoulder remains the primary driver of the U.S. augmentation market, we see meaningful traction in other anatomies, including the hip, knee, and ankle, which together represent over $40 million in addressable market opportunity. In other news regarding Integrity momentum, during the quarter, we received 510(k) clearance for two new Integrity shapes and sizes that are planned to launch in a limited release by year-end. These two new SKUs are designed to support repairs in both insertional and mid-substance Achilles tendon, patellar tendon, quadriceps tendon, and gluteus medius tendon, to name a few. The revenue contributions of these new shapes and sizes will be modest in the second half of this year as we continue to ramp up production and training activities. However, we expect them to positively impact future commercial sales for this critical product. This expansion further strengthens our ability to penetrate this addressable market and reinforces Integrity's position as a versatile and scalable regenerative platform. Let me now walk you through the high-level financial results for the quarter. I am pleased to report that we delivered financial results in line with expectations as we overcame difficult manufacturing yield challenges at the start of the quarter. I'm proud of the work that our teams have done to overcome these challenges despite the financial impact that it had in the quarter. Revenue in the quarter was down 8%. However, we continued to demonstrate strength in our commercial channel led by our regenerative solutions offerings, which were up 41%. Our OEM channel, although lower year-over-year, was in line with our expectations as J&J works to stabilize this important profitable channel for our business. In light of the near-term revenue pressure, we have taken proactive steps to reset our operating expense profile, driving a 17% reduction in total operating expenses year-over-year. Adjusted EBITDA was roughly flat for the quarter, while we continue to invest in our most promising commercial opportunities. Lastly, I will mention that we have successfully completed the material transition services activities with respect to the divestitures of both Parcus and Arthrosurface and are now fully focused on our strategy, leveraging our proprietary hyaluronic acid technologies.

Thank you, Cheryl. Before we dive into the financial results, I want to begin with an update on the production challenges we encountered earlier this quarter. Since April, our teams have successfully resolved the lower production yields and restored output to historic levels. While we experienced reduced shipments in April and May, I want to emphasize that this did not result in any delayed deliveries to patients. Toward the end of the quarter, we were modestly behind on certain international OA Pain shipments, which impacted commercial revenue slightly. However, we expect to fully recover and deliver product for these purchase orders in the third quarter. I'm proud of the cross-functional collaboration that enabled us to resolve this issue within the quarter, and we've implemented new procedures to help ensure that this type of disruption does not recur. With that, I'll now provide financial updates on the quarter. Please refer to Slide 4 of the presentation. In the second quarter, Anika generated $28.2 million in total revenue, an 8% decline compared to the same period in 2024. Revenue in our commercial channel, which includes our globally distributed, highly differentiated products, was flat year-over-year at $11.9 million. However, within this channel, regenerative solutions delivered standout performance, growing 41% year-over-year driven by continued momentum in the Integrity Implant System. Importantly, Integrity has now achieved sequential growth for five consecutive quarters and as of June, we've already exceeded full year 2024 revenue for the product on track to more than double in 2025. This underscores the strength of the platform and the growing demand we are seeing in the market. Offsetting this growth was a 10% decline in international OA pain sales, primarily due to approximately $900,000 in unfilled orders stemming from previously mentioned lower yields as well as a difficult year-over-year comparison due to the timing of shipments in Q2 2024. Absent the lower yields, we would have expected international OA Pain to be flat in the commercial channel to be up approximately 8%. With yields now fully restored, our teams are working diligently to fulfill backlog distributor orders and expect to recover these orders in the third quarter. Revenue in the OEM channel, which includes our domestic OA Pain and nonorthopedic products sold under long-term agreements, declined 13% in the second quarter to $16.3 million. This performance was in line with our expectations, reflecting continued pressure on demand and pricing for Orthovisc as well as lower pricing for Monovisc, offset partially by higher end-user volume. Monovisc pricing was stronger this quarter due to the timing of contractually obligated payer rebates from J&J, which, as with others in this market can vary significantly from quarter-to-quarter. We anticipate a pricing decline in Q3, followed by a modest rebound in the fourth quarter, with no change to our full year pricing outlook. While we do not directly control this channel, we remain actively engaged with our partner to drive for greater price stability and market expansion. Despite ongoing headwinds, Monovisc and Orthovisc continue to lead the U.S. market and remain profitable contributors to our business. The remainder of our OEM business, our nonorthopedic sales grew in the quarter due to the timing of customer orders. Second quarter gross margin was 51%, down 16 percentage points from the same period last year. The primary driver was a one-time $3 million charge related to the lower yields of Monovisc and Cingal in April and May. This charge, largely non-cash, represents the full extent of the lower yields and falls within the previously communicated range for the full year impact. Excluding this one-time item, gross margin would have been above 60% for the quarter. In addition, gross margins were impacted by a $3 million year-over-year decline in Monovisc and Orthovisc sales to J&J, primarily driven by lower pricing that impacts both transfer units and royalties and directly reduces gross profit. With the lower yields now resolved, we expect gross margins to improve in the second half of the year to the 58% to 59% range as we communicated on our first quarter call. That said, the combination of reduced high-margin J&J revenue and the first half manufacturing challenges will result in a lower overall gross margin for 2025. These dynamics were anticipated and are already reflected in our full year guidance. Turning to operating expenses. Total second quarter OpEx was $18.5 million, down $3.8 million or 17% compared to the same period last year. Selling, general and administrative expenses declined 22%, while research and development expenses were down 6%. The $3 million reduction in SG&A was primarily driven by a one-time non-recurring $1.6 million expense in 2024 and $1.4 million in headcount-related cost savings actions. As we've pivoted the strategic focus of the company, we continue to streamline and optimize our organizational structure to align with our future direction. These actions reflect our commitment to disciplined cost management and mitigating the impact of revenue pressures while continuing to invest in areas that support long-term growth. Adjusted EBITDA from continuing operations was negative $200,000 in the second quarter, a decline of $4.9 million compared to the same period in 2024. The decrease was primarily driven by the one-time scrap costs for our recent manufacturing challenges in addition to lower high-margin revenue from J&J, partially offset by the meaningful reductions in operating expenses. Without the one-time scrap costs, the company would have generated positive EBITDA in the quarter. Now turning to cash and liquidity. In the second quarter, we used $200,000 in operating cash flow, an improvement compared to the $1.1 million of cash used in the same period last year. This was driven by stronger working capital management and disciplined cost controls in response to revenue pressures. We invested $1.4 million in capital expenditures during the quarter, down $2 million year-over-year due to timing. These investments are focused on expanding capacity at our Massachusetts manufacturing facility to support anticipated volume growth across Monovisc, Cingal, Integrity, and Hyalofast. This will position us well to meet future demand and scale efficiently. We ended the second quarter with $53 million in cash and no debt. Now on Slide 5, I'll review our full year financial outlook for 2025. We are maintaining our 2025 full year guidance. For the full year, we continue to expect our commercial channel to generate between $47 million and $49.5 million in revenue, representing 12% to 18% growth in 2025. Our OEM channel remains on track to deliver between $62 million and $65 million, a range of 16% to 20% decline versus 2024. At the midpoint of down 18%, this range is reflective of higher volumes but lower pricing for J&J. As a reminder, J&J has full control of sales, marketing, and pricing activities for these products in the United States, and Anika receives transfer unit revenue and royalties based on J&J's end-user pricing. Now turning to profitability. We are maintaining our 2025 adjusted EBITDA guidance range of negative 3% to positive 3%. As a reminder, this range is reflective of three primary impacts, all of which we shared at the end of the first quarter. First, the impacts from lower manufacturing yields and scrap for Monovisc and Cingal experienced in the first half of 2025. Second, lower pricing from J&J for Monovisc and Orthovisc. And lastly, the 2025 costs associated with the Cingal bioequivalent study required for our NDA filing. As a result of the Hyalofast clinical trial outcomes, we are revising our long-term revenue guidance for the commercial channel to reflect a possible extension of the FDA review process. While we still plan to file the PMA in the second half of 2025, we are now modeling for a 12-month delay in launch timing. As a result, we are updating our commercial channel growth outlook to 10% to 20% in both 2026 and 2027 compared to our prior range of 20% to 30% growth. We currently anticipate a $3 million revenue contribution from Hyalofast in 2027 with full market release in 2028. These revised projections reflect growth from our already approved products, particularly Integrity and continued strength in our international OA Pain portfolio, both of which have demonstrated strong momentum. Despite this adjustment, our liquidity remains strong with no need to raise capital, and we remain confident in our ability to execute on our long-term strategy.

Thanks, Steve. In closing, we remain confident in the key value drivers of our business. Integrity continues to outperform expectations, and we anticipate double-digit organic growth in our commercial channel, consistent with our 2025 guidance. We have a clear path forward to complete the Cingal NDA submission. And while the Hyalofast trial did not meet its primary endpoints, we believe the totality of the data supports a viable path to FDA approval. I want to sincerely thank the entire Anika team for their continued dedication to delivering innovative solutions that improve the lives of patients around the world. And with that, we'll open up the line for questions.

Your first question comes from Anderson Schock with B. Riley Securities.

Congrats on a strong quarter. So your gross margin guidance of 58% to 59% implies gross margins returning to about 62% to 63% in the back half of the year. I guess what will drive the sequential improvement?

I appreciate the question, Anderson, and the chance to clarify. My commentary is that we expect 58% to 59% in the second half of the year. For the overall margin, it will be slightly lower than that for the full year due to the dynamics in the first half. We're confident in this because many of the charges from the start of this quarter are largely one-time events. Looking at the business performance without those charges, the business has done well this quarter. We also recognize that the gross margins for the second quarter, excluding the one-time impact, are above 60%, and we anticipate the second half will be slightly lower. This is primarily influenced by the pricing dynamics for J&J on Monovisc and Orthovisc that we expect in the latter half of the year.

Okay. Got it. And then do you have any progress to report on additional OEM partnerships to diversify your OEM revenue away from J&J?

Yes. In terms of kind of additional opportunities in the OEM channel, I don't have anything to report today. That is a topic that we continue to assess. And we have talked about the fact that Cingal will most likely fit into that OEM channel. And as we make continued progress really making meaningful progress here this year in getting closer to an NDA filing. That's certainly a topic that will become probably more visible as we move into the future.

Okay. Got it. Okay. Got it. And then I guess, Integrity has demonstrated some really impressive growth in the shoulder. How should we think about the expanded market opportunity with the new configurations for foot and ankle and also knee and hip?

Yes. Thanks for the question. What we've seen with Integrity is even with the current sizes that we sell that the surgeons are so excited about the benefits and features that Integrity provides them, especially on the enhanced regenerative capacity and the strength at time zero, even when it's wet, that in a lot of those other applications that I talked about today, where there's a real need for additional strength and future retention strength, they started using existing Integrity in those applications, but it wasn't really fit to purpose from a size and aspect ratio perspective. So they're excited to start using these new shapes and sizes in those other applications. I think while we've already been serving that additional kind of $40 million addressable market opportunity, we think these new shapes and sizes that are more purpose fit and designed specifically for those anatomic locations will give us an increased opportunity going forward. This year is really around a limited release and getting our feet under us from a manufacturing and training and education and marketing perspective. But we're excited to get those products out there this year, and we have a group of surgeons that are ready to go.

Okay. Got it. And then I guess on Hyalofast, given the missed primary endpoints, I guess, what gives you the confidence that the FDA could approve based on secondary endpoints in the international data?

Yes. It's a great question. So this product falls under the breakthrough device designation, and the FDA has encouraged us to file all of our data. The study was really primarily impacted by missing data from the complexities of randomizing to that microfracture arm and the change in medical practice that occurred over the time of the trial. And frankly, missed data that occurred during COVID, which the FDA actually put guidance out around because a number of trials were impacted by that dynamic over that time period. So FDA has encouraged us to submit our full data package, including the secondary endpoints that we did hit statistical significance on. Those secondary endpoints are what got used for other products that are currently approved in the United States, and we have a very complete data package and robust data package of independent studies that were performed from our over 15 years of clinical experience outside the United States.

The next question comes from Jim Sidoti with Sidoti & Company.

So with regard to gross margin, how should we think about gross margin going forward as the commercial channel becomes a bigger piece of the revenue part?

We haven't provided long-term guidance on where to expect gross margins in the future. However, I can say that the commercial channel currently has a lower gross margin because it includes our international products, which are generally sold at lower price points. In the future, I would expect gross margins to be in the range I've shared for the second half. There are two factors affecting this: the growth of the commercial channel, which may lower gross margin over time, and the growth of our newest products, which typically have higher margins. Hopefully, these higher margins will offset any declines from international growth. Overall, I anticipate gross margins will be in the range for the second half of this year.

Okay. But it sounds like as Integrity and hopefully Hyalofast get into the market, that those would be accretive to gross margin. Okay. And with regards to Cingal, Cheryl, you talked about the distribution a little bit. Could you sign a distribution deal prior to the release of the product? Or are you going to wait for FDA approval to announce something?

Yes. I'll tell you on that topic, my focus is in driving as much shareholder value as I can with that incredible product that has very exciting clinical data and a real opportunity in the U.S. market as a next-generation osteoarthritis pain product. So the decision around timing for that is really going to be driven around the best way to drive value. The good news is that we are making real progress with the FDA. We've got processes ongoing to overcome the final two filing issues and look forward once we begin that bioequivalence study to give a full update on the timeline of that program.

All right. And my last question is about cash flow. Although you don't provide specific guidance on cash flow, can we assume that cash on hand is likely at a low point now and that we should expect to see it increase moving forward?

We haven't given specifics on a cash balance forecast. I think what we have given some guidance around is that we expect to see improvements in operating cash flow. I think we demonstrated some pretty good controls here as we've come through the disposition of two businesses. Jim, the only thing that would cause us to have a lower cash balance would be associated with CapEx investments. So obviously, we've been making some strategic investments into our Massachusetts facility here, and that would likely cause us to have a little bit of a lower cash balance into the future, but we expect to hopefully offset some of that with some of the growth in operating cash flow.

So with regard to capacity, do you think by the end of the year, you'll have sufficient capacity to meet demand for Integrity, Cingal, and Hyalofast over the next several years?

I think it's going to be a continued investment that we're making into our facility. So it's something we'll be doing over a period of time. I think the level of CapEx that we forecasted for this year is appropriate for us to be able to meet the ramp for next year, but we'll be continuing to upgrade equipment, especially in preparation for Cingal as volumes for both Monovisc and Cingal continue to grow and our cross-link products are a little bit more complicated to make and require more investment.

The next question comes from Michael Petusky with Barrington Research.

So I guess, Cheryl, can you provide more detail about the reduced sample size and higher dropout? I believe there were initially 200 patients targeted in the Hyalofast trial. I'm curious, how many patients did you actually have full data on?

Thank you for your question, Mike. You're correct that the study was designed to enroll 200 patients. We experienced a higher dropout rate in the microfracture arm, primarily because changes in clinical practice led some patients to withdraw even before undergoing the surgery, as well as during the trial due to missed appointments. We haven't yet reported on the number of patients for whom we have complete data because our analysis is still ongoing. Once we finalize the full data analysis, we will provide more information. Additionally, we faced issues with missing data, largely due to COVID, which affected many clinical trials and prevented patients from returning for follow-up visits. This issue particularly impacted our ability to achieve statistical significance. However, Hyalofast consistently showed improvements compared to microfracture in terms of pain and function, despite the statistical significance not being met. We will continue to discuss these matters with the FDA, who has advised us to submit a complete data package that includes all analyses and additional endpoints used in previous approvals, along with a comprehensive dataset from our independent studies conducted outside the U.S. over the past 15 years.

Cheryl, I'm just curious because I don't know the answer to this. Is it typical for the FDA to sort of say in a case where you've sort of missed the primary endpoints, but we really encourage you to submit the full data package? I mean, is that just sort of template language that, hey, submit what you have and we'll take a look? Or is there actually something to be encouraged about in terms of what they've said to you regarding that matter?

Yes. I will just communicate to you that they have communicated to us to submit the full data package. They obviously understand that we have missing data. And again, we're not completely done with our data analysis, which is why we haven't put the actual data out until that's completed and QC-ed, which we will do at the point in time that, that's done. But FDA did communicate to us that they wanted us to submit the full data package, including all of those elements that I described. And to keep in mind, this is a breakthrough device.

It's a good question. The short answer is it is still on track as a $14 million investment into the business. The news around Hyalofast just got unblinded, so this is very new for us. But I would say that in terms of better cost discipline and thinking about where we can make strategic investments that are going to pay off for our long-term business, we are consistently doing that. I'm not going to share anything necessarily here, but I would say that we consistently look at where we're making investments to try to ensure that we're delivering the most optimal outcome for shareholders.

Let me just follow up. Is it possible that $14 million and even looking forward, internal investment you plan to make in '26, could that number be curbed at some point in the second half of this year?

Yes, it's possible. I mean maybe we'll share more in the future when we get to that point, but it's possible.

Okay. Great. And then just one last question, Cheryl. I’m wondering if you could provide any updates on integrity, specifically regarding search and adoption commentary or surgery numbers. I may have missed what you shared previously, so I apologize if that's the case.

Yes. I didn't give an update on surgery numbers because we were really more focused now on what we're driving from a top line perspective and the fact that we're on track to really double that business this year. I'm sure as we go forward, we'll continue to provide those updates. But you can just kind of extrapolate that based on the fact that we're really overachieving, we're ahead of expectations, and we're projecting to double that business this year.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.