Anika Therapeutics Inc.

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Good morning, ladies and gentlemen, and welcome to the NECA's first quarter earnings conference call. I will now turn the call over to Mr. Matt Hall, Executive Director, Corporate Development and Investor Relations. Please go ahead.

Good morning, and thank you for joining us for Anika's first quarter 2026 conference call and webcast. I'm Matt Hall, Anika's Executive 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, as are the supplementary PowerPoint slides that will be used for the discussion today. With me on the call today are Steve Griffin, President and Chief Executive Officer, and Ian McLeod, Senior Vice President, Chief Accounting Officer, and Treasurer. They will present our first quarter 2026 financial results and business highlights. Please take a moment and open the slide presentation and refer to slide two. 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 gross margin, 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 measures are available at the end of the presentation slide deck and our first quarter 2026 press release. With that context, I'll turn the call over to our president and CEO, Steve Griffin, to walk through our performance and discuss our priorities as we move forward. Steve?

Good morning, everyone, and thank you for joining us. In the first quarter of 2026, we made meaningful progress across Anika's three strategic priorities, driving sustainable commercial channel growth, advancing our hyaluronic acid-based innovation pipeline, and strengthening execution across our organization. Our first quarter performance reflects a more focused business with early benefits from the operational changes we've put in place. I want to walk through our first quarter results through the lens of these three priorities and importantly, in the context of what we said we would do. First, our top priority remains accelerating sustainable revenue growth, and the first quarter results reflect continued progress in that direction. In the first quarter, commercial channel revenue continued to grow at a double-digit rate, increasing 12%, reflecting strong performance across both regenerative solutions and our international OA pain management portfolio. Within regenerative solutions, Integrity continues to be a central driver of that momentum, with U.S. procedures up 35% year-over-year, generating nearly $2 million in revenue. Growth was driven by U.S. surge in adoption, the full launch of larger sizes, and expanding international penetration. We continue to be pleased with Integrity's performance as it progresses through the commercialization curve, having now surpassed 3,000 cases with accelerating adoption. We are seeing surgeons progress to their fifth and tenth integrity cases faster than initially expected, with acceleration evident across each stage of adoption. This reinforces that once surgeons begin using integrity, utilization ramps quickly as confidence builds. We are closely tracking new surgeon adoption, with new surgeon users per month growing at a double-digit rate month over month. This reflects continued success, both in expanding our surgeon base and in deepening engagement as surgeons increase their use of integrity over time. We're pleased by early results following the launch of the larger integrity sizes, with demand tracking ahead of expectations. But the bigger opportunity is adoption. Today, augmentation is used in only about 8% of rotator cuffs in the US. In other words, more than 90% of patients do not receive a patch at all, even though we know augmentation can support better healing. Our strategy is to change that. By expanding the integrity platform with additional sizes, configurations, and enabling instrumentation, we aim to make augmentation easier for surgeons to adopt. Over time, that can both improve patient outcomes and significantly expand the total addressable market for integrity in the ASC. Hylafast also continues to contribute to the strength of our regenerative solutions portfolio, delivering steady growth outside the United States, supporting overall commercial channel performance. International demand remains solid, driven by established clinical adoption and continued expansion across key markets, underscoring Hylafast's role as a durable contributor to our regenerative platform and a complementary driver alongside newer products within the portfolio. Turning to our international OA pain management portfolio, we delivered strong first quarter revenue of nearly $9 million, reflecting the continued strength of our commercial channel. Performance was driven by ongoing regional expansion and improved market share across multiple geographies for Syngal, Monovisk, and Orthovisk. Lastly, The OEM channel grew 14% year over year, primarily due to favorable order timing for both our US OA pain management products sold through our partnership with J&J MedTech and our non-orthopedic products. We continue to expect quarterly variability in this channel. Within the US OA pain management portfolio, performance was driven by monovisc unit volumes that exceeded our internal projections for the quarter. With pricing tracking in line with expectations, Monavis delivered meaningful favorability and more than offset lower than expected demand for OrthoVisc. This product level mix shift highlights the inherent variability in our OEM channel, where timing and demand can differ by product and quarter without changing our full year expectations. Non-orthopedic revenue was up in the quarter, driven by order timing of our animal health products. As a reminder, we continue to assess optionality as legacy distribution agreements cycle through with a clear focus on maximizing shareholder value. Our second priority is advancing our HA-based innovation pipeline, centered on Integrity, Hyalafast, and Syngal, and doing so through a structured and predictable development approach. During the first quarter, we continue to make steady progress across each of these programs. The HylaFast PMA review is ongoing as we continue to engage with the FDA through their review process. Syngal also advanced during the quarter. Enrollment in the bioequivalent study remains on track as we continue to prepare for an NDA submission, including the necessary CMC work to support hyaluronic acid as a drug. In addition, Syngal has successfully achieved European Union MDR certification, becoming our third MDR-certified product alongside Monovisc and Hyalofast. Importantly, the certification includes expanded indications across multiple joints, including the knee, hip, shoulder, and ankle, reinforcing Syngal's clinical versatility and supporting continued international growth. In parallel, the post-market clinical follow-up study supporting marketing in the Integrity EU MDR submission continues to enroll, and remains on track to complete enrollment later this year. We began 2026 with a clear focus on execution, and the progress delivered in the first quarter underscores that commitment. Within our regenerative pipeline, we are advancing an early stage regenerative suture and tape program that underscores the meaningful potential still to be unlocked from our hyaluronic acid technology platform. Leveraging high F fiber, we can tailor both mechanical strength and biological response to specific soft tissue and tendon repair needs across a broad range of clinical applications. While development remains early, and we are not yet quantifying its financial impact, the preclinical data are very encouraging, and we look forward to sharing more as this and other programs progress. Our third priority, strengthening operational discipline and execution, has been an increased area of focus. and it was a significant contributor to our first quarter financial performance. Gross margin improved meaningfully compared to the first quarter of 2025. That improvement reflects a combination of higher manufacturing productivity and throughput, the continued benefits of our margin improvement initiatives, and greater discipline across our operations. As a result, adjusted EBITDA increased by more than $4 million compared to the first quarter of last year. Importantly, these results are not the outcome of a single quarter or a one-time action. They are being delivered through deliberate operational transformation that embeds lean manufacturing principles across our operations with a strong focus on continuous improvement and empowering our teams. We've reduced non-standard work, strengthened engineering solutions, and improved productivity by enabling teams closer to the work to drive meaningful change. At the same time, Targeted investments and equipment upgrades have supported these efforts, allowing us to execute more efficiently and with greater consistency. Collectively, these actions are changing how we run the business, tightening processes, increasing operational discipline, and building a more scalable operating model as volumes grow. While we don't expect margin performance to move in a straight line each quarter, the first quarter provides clear evidence that our operational transformation is underway and beginning to create meaningful operating leverage in the business. On the expense side, we continue to demonstrate strong cost control across the organization. Excluding one-time severance charges related to actions we took earlier in the year, SG&A remained well managed, reflecting the benefits of a more focused operating model and disciplined resource allocation. R&D expenses increased this quarter as expected, reflecting deliberate investment in our key pipeline programs. These investments are targeted and aligned with their advanced programs we believe offer the greatest potential to drive future growth and value creation. With that, I'll turn it over to Ian to walk through the financial details.

Thanks, Steve. Please refer to slide five of the presentation as I provide updates on the first quarter of 2026. In the first quarter, ANACA generated $29.6 million in total revenue, up 13% year-over-year. Commercial channel revenue grew 12%, reaching $12.6 million, driven by strong international execution and continued momentum and integrity, which continues to exceed our commercial expectations. Our international OA pain management business remained a key contributor. delivering 9% growth in the quarter to $8.9 million in revenue, led by sustained market share gains for Monavis and Sincol across several regions. OEM channel revenue was $17 million in the quarter, representing a 14% increase year-over-year. The increase was driven primarily by order timing, including shipments of U.S. OEPA management products sold through J&J MedTech, as well as certain non-orthopedic OEM products As we have discussed, the OEM channel is subject to variability related to customer order patterns. As a result, some revenue shifted into the first quarter, which may affect reported OEM revenue in the second quarter. Importantly, this timing-related variability does not change our expectations for the full year. Our gross margin improved in the first quarter, driven by higher volumes and improved execution across our manufacturing operations. GAAP gross margin increased to 64%, up from 56% in the prior year, reflecting higher productivity, increased throughput, and the early benefits of our lean manufacturing efforts. Turning to operating expenses, first quarter operating expenses were $24.5 million compared to $19 million in the prior year period. Selling, general, and administrative expenses increased to $17.8 million from $12.9 million a year ago. primarily reflecting $4.9 million of one-time severance-related costs associated with previous announced cost reduction actions. R&D expense was $6.6 million, up 11% from $6 million a year ago, driven by continued investment in key regulatory and clinical programs, including Hyall, Faskins, and Gall. We are continuing to closely monitor operating expenses, balancing discipline spending with targeted investment in the program's most critical to long-term growth. Total adjusted EBITDA for the quarter was $4.3 million, driven by strong gross margin expansion and improved operating leverage. We ended the quarter with $41 million in cash with no debt, giving us a strong liquidity position and the flexibility to continue investing in our growth priorities. First quarter cash usage reflected typical seasonal expense dynamics, and we expect cash flow to improve as the year progresses. As previously communicated, we initiated a $15 million 10b-5-1 stock repurchase plan in November 2025, and as of April 10th, that program has been completed. As part of the second 10b-5-1, we had purchased $15 million of stock at an average price of 1076. Now please turn to slide 6 as I review our financial outlook for 2026. Based on our first quarter performance and current visibility across the business, we are maintaining our previously issued full-year 2026 guides. At the total company level, we continue to expect full-year revenue of 114 to 122.5 million. representing 1% to 9% year-over-year growth. This outlook reflects continued momentum in our continued commercial channel alongside the market dynamics we've discussed in our OEM business. Within the commercial channel, we are maintaining our expectation for 10% to 20% growth, or 53 to 58 million for the full year. Growth is expected to be driven by the ongoing expansion of integrity in the U.S., sustained high ALIFAS performance outside the U.S., and increasing adoption across our international OEP management portfolio. For the OEM channel, we continue to expect revenue to be flat to down approximately 5% year-over-year, or $61 to $64.5 million. This outlook reflects anticipated monovisc unit volume growth, partially offset by lower pricing. Turning to profitability, we are maintaining our expectation for adjusted EBITDA to be in the range of 5% to 10% of revenue. At the midpoint, this improvement is driven by higher expected revenue led by commercial channel momentum along with the benefits of previously announced G&A cost reduction actions and continued productivity and manufacturing improvements as demonstrated in the first quarter. These gains are partially offset by modestly lower J&J MedTech pricing. With that, I'll turn the call back over to Steve.

Thanks, Ian. As we continue the transformation of the company following our divestitures in 2025, the board is also evolving to reflect this next phase, and two directors will be stepping down, as outlined in the proxy filed last night. We are grateful for Dr. Glenn Larson and Bill Jellison's contributions and valuable service to the company. With that context, before we move to Q&A, I want to briefly reinforce what we're focused on and how we're operating. Our priorities are clear. First, we are continuing to drive revenue growth across our commercial channels. Second, we are advancing our HA-based innovation pipeline through key regulatory milestones in a disciplined and predictable way. And third, We are building on the progress we've made operationally to support improved profitability and long-term scalability. Equally important is how we're going about this. We are running the company with a simple operating mindset built around two principles broadly shared by the best lean manufacturing systems. First, respect for people, and second, continuous improvement. Respect for people means recognizing that the most important work happens closest to our products and our customers. Leaders exist to support that work, to simplify processes, remove obstacles, and make it easier for teams to execute and improve every day. Continuous improvement is about being practical, disciplined, and honest about where we can do better and then acting on it. This approach is helping us operate more effectively, staying close to customers and surgeons, and running the business with a leaner, more focused leadership structure while maintaining strong accountability and execution. I want to thank our employees across the company who are embracing this way of working and showing up every day focused on execution and improvement. I'd also like to thank the surgeons and patients who rely on our products and partner with us. We value that trust and it keeps us focused on delivering consistent quality and performance. And finally, I want to acknowledge our shareholders. We appreciate your support and engagement as we make these changes to work to build a stronger, more durable business. Your interests are aligned with ours and those of our employees and customers as we focus on long-term value creation. With that, I'd like to now open it up for questions.

Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. And your first question comes from Mike Petesky from Barrington Research. Please go ahead.

Hey, good morning. So I guess the first question I have is sort of around gross margin. Obviously, a really good quarter in terms of gross margin with some favorable order timing, or I should say favorable mix particularly, I think, and obviously getting some benefit from manufacturing efficiencies. I guess going forward, I'd assume probably upper 50s for most of 26, I mean, is that the right way to model this as things sort of normalize in terms of mix or, you know, might 60% or very low 60% be more the new normal going forward? Thanks.

Yeah, good morning, Mike. Thanks for the question. I think the first quarter is a demonstration of what we can do, and I think the lean manufacturing improvements that we've made are starting to show through. You are correct that we received some favorability in the first quarter as it relates to mix and some of the order timing on the OEM side. that benefits the overall business. And so I do think that it will be likely lower over time. And it's going to vary quarter to quarter. I haven't given a specific guide, but it's implied through the EBITDA guidance that we don't expect it to maintain at the same level as it's at in the first quarter. But I think it is a good demonstration of what we're shooting for. Longer term, beyond just the course of this year, we're focused on improving the manufacturing productivity so that we can reduce our cost per unit as we continue to scale and grow operations. And I think this is an important step in that right direction.

Okay, great. And Steve, you gave a lot of detail, and I really appreciate it. I'm sure other people really appreciate it around integrity and utilization and the footprint you're building out there with surgeons, et cetera. So given the opportunity that you described, how do you guys apply I guess approach that in terms of training surgeons. I mean, is there sort of a cadence, a rhythm that you all are going out and trying to achieve? Like what's the plan there to sort of get after that 92% of the market opportunity you don't think you're touching now?

Yeah, it's an excellent question, and I would say we've talked in the past about the investment that we've made in our commercial channel. It's primarily related to the need to train surgeons on the procedure, and that's really where we've spent a lot of our time and focus is on that new surgeon adoption. We closely monitor and track how long it takes the surgeons to get to that fifth and tenth case because that's really an indication of how well they're getting through the learning curve of the product. And that's been sort of our primary focus with the team that we have that are boots on the ground that have done a really great job of establishing a footprint here in the US. I think the broader question you're asking about in terms of how big the total addressable market is just given sort of the current rotator cuff augmentation. percentage rates is another clear indication of where we want to try and grow. And that's going to come not just from surgeon adoption, but also from ease of use and the different sizes and shapes and instrumentation that we can deploy. And I think that we've got a really interesting product here from its regenerative capability and where we're focused on for R&D in the HA, high F space in the U.S. is around trying to make that easier so that surgeons are able to deploy it more rapidly to more patients. So it's not just the adoption, but it's also the R&D efforts in that space. And that plus the clinical data that we're working to gather are sort of all part of our plan as we launch this U.S. commercial channel.

Okay. Steve, I don't think I asked that question as well as I wanted to. I'm going to take a second shot at it. Is there targets internally, and I'd love if you'd be willing to share some of it, in terms of how many trainings, how many new surgeons you want to train on integrity over the course of 26? Are there targets that you guys are trying to achieve there?

Yeah, I appreciate the question. I'll answer it super simply. Yes, we have targets. Yes, our team works against those to try and get new surgeons adopted to the technology. And no, we're not going to share those externally.

All right. Hey, last question for me, at least for now. In terms of the share repurchase, obviously, completed it. Congratulations. Congratulations, particularly on the cost basis of those shares that you all repurchased. I guess my question is, given $40 million of cash on the balance sheet, as you look at sort of capital allocation priorities post the completed share repurchase, what would you call out there in terms of your priorities going forward? Thanks.

Yeah, I appreciate that question. Certainly, the share repurchase is part of a broader capital allocation strategy at the company level. And when we think about capital allocation, there's a few different facets to it. First is the operational investments we've made. So we've made investments in the CapEx in our manufacturing facility, and those are important to allow us to drive growth and scalability. Second will be the investments we've made into our U.S. regenerative commercial channel. So that's been an investment that we've talked about historically as something that's a drag to the P&L, we think of that really as a capital allocation decision we're making. And then as we think about capital allocation longer term, the share repurchase opportunity is certainly a piece of it. You know, we think about that in the sense that it represents a long-term shareholder value, and we think that the shares today represent value, but we're also considering other elements of the business associated with the long-term potential and where we see our business headed. And at this point, we have nothing further to share.

Okay, very good. Thank you. Thank you.

Thank you. And your next question comes from Anderson Shook from B. Reilly Securities. Please go ahead.

Hey, good morning. Thank you for taking our questions, and congratulations on the strong quarter. So you mentioned that HylaFAST review timeline remains intact. Could you remind us that timeline and when you expect to submit the complete response and your working assumptions for an FDA decision window?

Absolutely. Appreciate the question this morning. So we had previously communicated from an impact to ANACA's revenue opportunity that it could impact the fourth quarter of next year. That's built into our guidance. And with that as an expectation of sort of an extended timeframe of discussions with the FDA. As you noted, we did submit the third and final module in the fourth quarter of 2025. And we received the deficiency letter from the FDA in the first quarter of this year. And we're working on those responses. We haven't given a specific timetable as to when we expect to have our full response back into them, but it's safe to say that, you know, it's in the coming months in terms of what we're planning on submitting back to them. And then we expect to have a back and forth with them associated with the previously announced clinical data.

Okay, got it. And 2027 guidance remains unchanged. So I guess at what point in the year would you need a positive FDA decision to have enough lead time to ramp commercial infrastructure to support the expected 3 million of 2027 U.S. HyloFast revenue?

Yeah, I think it's safe to say that we've built in a level of buffer in terms of what we think we would need for the commercialization ramp up to support our business. Everything that we've kind of built into our assumption here of our back and forth with them is kind of built into that overall financial framework. You know, our teams are obviously working internally on the things that we can do now in support of a potential launch of HyloFast and then a ramp further in next year would be decisions we would make depending upon FDA.

Okay, got it. And then could you provide an update on singles bioequivalent study enrollment to date? Does the current enrollment pace allow you to provide more specific completion in NDA filing window?

It doesn't, but I expect that as we continue to work our way through that, we will be in a position to share more associated with an NDA filing timeframe. As you noted, we are working through sort of the two elements of it, which is the bioequivalence study, which I'm not going to share the specific numbers, but it remains on track versus our original expectations as we've started this year. I think we noted on our fourth quarter call that we had initiated the study in the December timeframe of 2025, and so the pace of enrollment is on track. And then we're working on in conjunction with preparation of the CMC work to be able to file for HyloFast as a drug. So those two things are running concurrently.

Okay, got it. And then finally, you mentioned a new regenerative sutures and tapes program in development. Could you provide some more color on the size of the market opportunity here?

Yeah, I'd say it's a little early. I noted in the prepared remarks that we're not going to necessarily share, I'll call it financial projections of this because it's still early. Really what we wanted to do was just highlight the opportunity that exists for HIAF as a regenerative technology in spaces that are outside of the areas that we're currently covering. Certainly, suture tape is the space that we think would be most opportunistic. It's a very large addressable market, but that doesn't mean that it would be entirely addressable for us. But it's an area for where we think about regenerative technology in the long term. It could have a bigger impact. I don't think we're at the point yet to share more on that, but the early indication we have on some of the data we've seen has been encouraging.

Okay, got it. Thank you for taking our questions. Of course, thank you.

Thank you. And there are no further questions at this time. Mr. Steve Griffin, you may please proceed.

Thank you. Thank you, everybody, for joining our call today, and we look forward to speaking with you on our second quarter earnings call.

Ladies and gentlemen, this concludes your conference call for today. We thank you very much for your participation. You may now disconnect. Have a good day.