Anika Therapeutics Inc.

Good evening, ladies and gentlemen. Welcome to ANACA's fourth quarter and year-end earnings conference call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. Also note that this call is being recorded on Wednesday, March 12, 2025. I will now turn the call over to Matt Hall, Director, Corporate Development and Investor Relations. Please go ahead, sir.

Thank you, Sylvie. Good evening, and thank you for joining us for ANACA's fourth quarter and year-end 2024 conference call and webcast. I'm Matt Hall, ANACA's Director of Corporate Development and Investor Relations. Our earnings press release was issued earlier this afternoon and is available on our Investor Relations website located at www.anaca.com, as are the supplementary PowerPoint slides that will be used for the discussion today. With me on the call today are Dr. Cheryl Blanchard, President and Chief Executive Officer, and Steve Griffin, Executive Vice President, Chief Financial Officer, and Treasurer, who will present our fourth quarter and year-end 2024 financial results and business highlights. Please take a moment and open the slide presentation and refer to slide number 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 measurements are available at the end of the presentation slide deck and our fourth quarter and full year 2024 press release. And now I'd like to turn the call over to our President and CEO, Dr. Cheryl Blanchard. Cheryl?

Thanks Matt. Good afternoon everyone and thank you for joining us. Please turn to slide three. I'm pleased to report since our last call that we've made meaningful progress advancing our strategic initiatives and refocusing our strategy. As we've communicated, a key objective has been to focus our human and financial capital on our most promising opportunities to create shareholder value. As a result, We divested Arthrosurface in Q4 of 2024, and last week announced that we have completed the sale of Parkis Medical. These divestitures align with our focus to capitalize on our core HA products that provide us with the best value-building opportunities, including the Integrity Implant System and the U.S. approvals of Hylafest and Syngal. I'll start today by sharing our financial results for the quarter and full year. Overall revenue in the fourth quarter was $30.6 million, up 1% compared to the same period in 2023. For the year, revenue was $119.9 million, a slight decrease of 1% compared to 2023. Commercial channel revenue was up 25% in the quarter and 17% for the full year. while OEM channel revenue decreased by 8% for the quarter and the full year, consistent with our expectations. During the fourth quarter, we delivered 22% international OA pain management growth and 16% growth for the full year. This success was driven by continued geographic expansion and market share gains, highlighting our robust international presence. Our efforts to penetrate new markets and strengthen our distribution networks have paid off. and we are committed to further expanding our global footprint. In 2024, we made significant progress across the refocused company. We executed on key objectives that drove strong growth in our commercial channel, fueled by continued gains in our international OA pain management business and further acceleration of integrity. We sharpened our strategic focus on HA-based products and achieved important milestones in our commercial, regulatory, and clinical trial goals. During the quarter, Integrity realized more than 40% sequential growth with more than 300 surgeries performed in the quarter and now over 1,000 globally since its launch. This marks the third sequential quarter that we've achieved greater than 40% quarter-over-quarter growth. This impressive growth is attributed to the superior regenerative properties and mechanical strength of integrity compared to collagen scaffolds. These key attributes of integrity have resulted in a strong pull from surgeons. In February, we released a white paper summarizing the early clinical results from our first post-market study of 29 patients with partial and full thickness rotator cuff tears. The results showed significant and clinically meaningful improvements in pain and strength at three months and further improvements in pain, range of motion, and strength at six months, with no evidence of any re-tears at six months or device-related complications. This data has been well received, leading to increased adoption, and we continue to hear positive feedback from both surgeons and their patients. As a result of our successful commercial launch, we captured more than 1% of the 2024 U.S. soft tissue augmentation procedures in our first six months of full market release. We believe integrity will continue to drive significant commercial channel revenue, contributing to our long-term revenue targets and market expansion plans. To further accelerate growth in our commercial channel, we continue to advance our integrity technology platform to add additional near-term regenerative solutions products to our pipeline. As mentioned on our Q3 call, we've partnered with a team of leading surgeons to develop new shapes, sizes, and configurations of Integrity. We are on track to begin introduction of those new product line extensions to the U.S. market later this year. Additionally, we've enrolled our first patient in the prospective clinical study for Integrity. This study will provide valuable, real-world evidence that will enhance Integrity's position in the market, support expanding sales efforts and marketing efforts, and drive further commercial growth. We anticipate that the data from this study will reinforce the clinical benefits and safety profile of Integrity, further solidifying its market position. Data from this study will also be used for submission to the EU for MDR approval. We also made significant regulatory and clinical progress with our key pipeline programs. In January 2025, we filed the second PMA module for Hyalofast, our single-stage, off-the-shelf, proprietary hyaluronic acid scaffold for cartilage repair, which is already sold in over 35 countries outside the U.S. We expect to file the third and final clinical module in the second half of this year with a U.S. launch planned by 2026. We also reached another key regulatory milestone for Hylafast, receiving MDR approval in February. Hylafast has shown continued market-leading positions in geographies where it's sold, and we're excited about its potential to address significant unmet needs for cartilage repair patients in the U.S. Finally, Syngal, our fast-acting, long-lasting, non-opioid OA pain product, also saw important advancements. We held a productive type C meeting with the FDA in February to help finalize the bioequivalence bridging study design. We are awaiting formal feedback from the meeting and plan to share further updates to investors as we move forward. We also started the final non-clinical toxicology testing in Q1 of this year. The feedback from international markets has been overwhelmingly positive and we believe Syngal will be a market driving force in the next generation OA pain management segment. And with that, I'll now turn the call over to Steve for a detailed review of our financial results.