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Anika Therapeutics Inc.
7/29/2026
Good morning, ladies and gentlemen, and welcome to the ANACA's second quarter earnings conference call. I would now like to turn the call over to Mr. Matt Hall, Executive Director of Corporate Development and Investor Relations. Please proceed.
Good morning, and thank you for joining us for ANACA's second quarter 2026 conference call and webcast. I'm Matt Hall, ANACA'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.annika.com as the supplementary PowerPoint slides that will be used for the discussion today. With me on the call are Steve Griffin, President and Chief Executive Officer, and Ian McLeod, Senior Vice President, Chief Accounting Officer, and Treasurer. They will present our second 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 today's 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 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 the 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 are available at the end of the presentation slide deck and our second 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 moving forward. Steve?
Thanks, Matt. Good morning, everyone, and thank you for joining us. The second quarter marked great progress in our efforts to build a stronger, more profitable ANACA. We delivered commercial channel revenue growth, significant gross margin expansion, our highest adjusted EBITDA since 2020, and improved profitability while continuing to invest in our growth initiatives. These results reflect execution against the three strategic priorities I highlighted in my first earnings call in February, accelerating sustainable revenue growth, driving operational excellence across the organization, and advancing our hyaluronic acid-based innovation pipeline. Our first priority remains accelerating sustainable revenue growth, and the second quarter results reflect progress in that direction. In the second quarter, commercial channel revenue increased 17% to a record level. This was driven by focused execution and broad growth in our international OA pain management and regenerative solutions businesses. The momentum was evident in our international commercial business, where focused execution and portfolio alignment continued to deliver results. Singhal grew 32% and Monavis grew 24% year over year, together contributing approximately $2 million of incremental profitable revenue. The growth we've seen through the first half of the year, with Singhal growing 23% and Monavis growing 19%, has contributed more than $3 million of incremental revenue. These results underscore the durability and growing scale of our international OA pain management franchise. We believe this sustained growth also reflects the benefits of the increased focus and alignment across our international business following the portfolio actions completed over the last 18 months. During the quarter, we hosted our international distributor meeting with more than 35 of our international distributors represented. providing an opportunity to align around growth priorities, share best practices, and strengthen commercial execution. As our organization and distribution partners increasingly concentrate their attention on our core HA portfolio, we are seeing improved engagement, greater market focus, and stronger execution, which we believe is contributing to the growth trends we are seeing today. Within regenerative solutions, integrity remains a growth driver. Global surgeries and units sold increased both sequentially and year-over-year, with year-to-date sales up approximately 39% and revenue just under $2 million for the second consecutive quarter. Growth was driven by expanding international demand and continued adoption of the larger sizes introduced late last year, reflecting increased surgeon confidence and broader utilization of the platform across a variety of anatomies and tendon applications. We remain encouraged by the progress of integrity. The recently launched larger sizes have exceeded our initial expectations, supporting our view that the platform can address a broader range of tendon repair procedures and patient anatomies. We also continue to advance our post-market clinical follow-up study, with enrollment expected to be completed in the coming quarters, further strengthening the clinical evidence, supporting the technology, and providing the data needed to file in the EU. Internationally, momentum remains positive, with stocking orders outside the U.S. increasing more than 50% in the second quarter and June representing the strongest month to date. As product availability expands and search and experience grows, we believe Integrity is positioned to support continued adoption across both U.S. and international markets. The strength of our high-app-driven regenerative business extends beyond Integrity. Hyalafast performed well during the quarter outside the U.S., contributing to double-digit growth in international regenerative solutions revenue. Its sustained adoption and expanding use across geographies highlight the strength and depth of this regenerative hyaluronic acid-based technology. Together, these drivers continue to enhance the franchise's reach and support sustainable long-term growth. The OEM channel grew 14% year-over-year. driven primarily by favorable order timing across both of our U.S. OA pain management products sold through our partnership with J&J to Pew Synthes. Within the portfolio, performance was led by monovisc unit volumes that exceeded projections for the quarter. Supported by favorable U.S. end market sales, monovisc more than offset lower than expected orthovisc revenue. While we believe a portion of the quarter's performance benefited from order timing, Underlying demand trends remain encouraging. Given our performance through the first half of the year, we're raising our full-year OEM revenue guidance, expecting low single-digit revenue growth. We continue to anticipate quarterly revenue variability due to customer ordering patterns. The current diffuse in these teams has driven improved demand and enhanced commercial execution. Their focus on physician outreach and many more. We have several long-standing OEM relationships and many more. Strengthening operational discipline and execution has been an increased area of focus and contributed to second quarter financial performance and profitability. Gross margin improved to 65% in the second quarter, representing one of the highest levels we have delivered in recent years. This performance reflects progress across manufacturing productivity, operational efficiency, product mix, and disciplined execution throughout the organization. Many of the operational improvements contributing to these results are structural. During the first half of the year, we completed several projects to address manufacturing constraints. On our monovisc and Syngal manufacturing line, we completed a capacity expansion project that effectively doubled throughput at a production step that had previously constrained manufacturing output. We also successfully completed a planned upgrade of our orthovisc and non-orthopedic manufacturing line. resulting in meaningful improvements in yield, throughput, and production efficiency. These investments strengthen our ability to support future growth while further improving the efficiency and cost structure of our manufacturing operations. Through the first half of the year, we've increased our focus on improving how we can run our core business, and those efforts contributed to our strongest quarterly profitability performance since 2020. We view current performance as evidence that we are building a more efficient, higher return business, and our teams believe we are in the early innings of improving returns. Our focus remains on applying lean principles across the organization, eliminating waste, simplifying processes, and improving productivity. Here in Bedford, we're optimizing our manufacturing operations to increase throughput and maximize facility utilization. We have added targeted headcount to support higher production levels while still increasing gross margin, enabled by process improvements, waste reduction, and a greater focus on value-added activities. In addition, we continue to make capital investments to enhance manufacturing capabilities, increase efficiency, and support future volume growth. Our manufacturing capabilities are becoming increasingly important competitive advantage and we believe they can create additional value over time. While we're encouraged by the early progress made to date, we believe opportunities remain to increase throughput through our facility, improve productivity and deliver higher profitability. Turning to our third priority, advancing our HA-based innovation pipeline, we continue to make progress across our development programs while building capabilities we believe will strengthen the long-term value of our innovation platform. Our strategy remains focused on leveraging our deep expertise in hyaluronic acid and HIAS technologies to address unmet needs across OA pain management and regenerative solutions. Starting with Hyalofast, we remain actively engaged with the FDA as the PMA review process continues. We are working through the agency's deficiency letter and expect to complete our response in the coming weeks. Based on our recent engagements, The co-primary endpoints of our clinical study are the most important components of the review and could impact the timeline for ultimate product approval. While the timing of an approval remains outside of our control, our confidence in the long-term opportunity for HyloFast remains unchanged. Importantly, the product continues to perform well outside the United States, contributing to double-digit revenue growth and international regenerative solutions revenue during the quarter. Continued adoption across multiple international markets reinforces the clinical value of the product and the strength of our regenerative solutions portfolio. We remain fully committed to bringing Hyalofast to patients in the United States and completing the PMA process. Turning to Singhal, enrollment in our bioequivalent study continues to progress as planned. As the program advances, the primary focus increasingly shifts to the chemistry, manufacturing, and controls activities. required to support the NDA submission. Syngal is regulated as a drug-drug combination product, creating a substantially different regulatory and manufacturing framework for hyaluronic acid. As a result, establishing the manufacturing and quality systems necessary to support hyaluronic acid as a drug is a critical component of the program. To support these efforts, we have expanded our CMC capabilities this year and are making targeted investments in manufacturing HA as a drug to ensure we meet FDA's drug manufacturing requirements. These necessary CMC activities will likely be the final work stream completed before the NDA submission. This investment will also improve manufacturing scale over the coming years. Beyond these later-stage programs, we continue to focus on long-term growth potential to unlock value from our hyaluronic acid and HyAP platforms. Our regenerative suture intake program continues to make encouraging early progress and highlight the versatility of our HIAAF fiber across soft tissue repair applications. More broadly, we remain focused on identifying and advancing differentiated applications where our biomaterials expertise can create meaningful clinical and commercial value. With that, I'll now turn the call over to Ian to walk through the financial details.
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