Stephen (Steve) Griffin, Current Chief Financial Officer and Chief Operating Officer, Appointed President and Chief Executive OfficerCheryl Blanchard to Become Executive Chair of the Board of Directors BEDFORD, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global leader in the osteoarthritis (“OA”) pain management and regenerative solutions spaces focused on early intervention orthopedics, today announced that Stephen (Steve) Griffin, current Executive Vice President, C ...

Group 1 - Anika Therapeutics, Inc. is under investigation by Kirby McInerney LLP for potential violations of federal securities laws or unlawful business practices by the company or its senior management [1] - On July 30, 2025, Anika announced topline results from its clinical trial of Hyalofast, which showed improvements in treated patients but did not meet pre-specified co-primary endpoints due to a higher dropout rate and missed visits during COVID [2] - Following the announcement, Anika's share price fell by $3.06, approximately 27.42%, closing at $8.10 per share on the same day [2] Group 2 - Investors who purchased or acquired Anika securities and have information regarding the investigation are encouraged to contact Kirby McInerney LLP for further discussion about their rights or interests [3] - Kirby McInerney LLP specializes in securities litigation and has achieved recoveries totaling billions of dollars for shareholders [4]

Core Viewpoint - Anika Therapeutics, Inc. is under investigation for potential violations of federal securities laws and unlawful business practices following the release of disappointing clinical trial results for its product Hyalofast [1][3]. Group 1: Investigation Details - The law firm Kirby McInerney LLP is leading the investigation into Anika Therapeutics [1]. - The investigation focuses on whether Anika and/or its senior management engaged in unlawful practices related to the company's securities [1]. Group 2: Clinical Trial Results - On July 30, 2025, Anika announced topline results from a clinical trial of Hyalofast, which is a resorbable hyaluronic acid scaffold for cartilage repair [3]. - The trial showed consistent improvements in treated patients compared to microfracture, but did not meet its pre-specified co-primary endpoints [3]. - Factors affecting the trial results included a higher dropout rate in the microfracture arm and missed visits during COVID, leading to missing data and a reduced evaluable sample size [3]. - Following the announcement, Anika's share price fell by $3.06, or approximately 27.42%, closing at $8.10 per share [3].

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $27.8 million, a 6% decline compared to the same period in 2024 [16] - Adjusted EBITDA from continuing operations was positive at $900,000, a decline of $3.7 million year over year [22] - Gross margin was 56%, a decrease of 10 percentage points year over year, but an improvement of 5 percentage points sequentially from Q2 [19] Business Line Data and Key Metrics Changes - Commercial channel revenue grew 22% year over year to $12 million, driven by a 25% increase in regenerative solutions [16][18] - OEM channel revenue declined 20% to $15.8 million, primarily due to pricing pressure [18] - Integrity procedures in the U.S. grew for the sixth consecutive quarter, with a projected doubling of procedures and revenue in 2025 compared to last year [7][17] Market Data and Key Metrics Changes - International OA pain management revenue grew 21% year over year, with year-to-date growth at 6% [9][18] - Cingal injections surpassed 1 million since its launch in 2016, indicating strong uptake outside the U.S. [9] Company Strategy and Development Direction - The company is focused on executing its product growth strategy and enhancing operational performance to create shareholder value [14] - A second $15 million share repurchase program has been initiated, reflecting a commitment to returning capital to shareholders [24] - The company is advancing toward key regulatory milestones, including the NDA submission for Cingal and the PMA submission for Hyalofast [14][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stability of the OA pain management business despite Johnson & Johnson's separation of its orthopedic business [6] - The company anticipates flat to modestly lower revenue in the OEM channel due to ongoing pricing pressure but expects unit volume growth to offset this [18] - Management remains focused on improving expense profiles to deliver positive operating cash flow and sustainable returns for shareholders [25] Other Important Information - The third and final PMA module for Hyalofast was submitted to the FDA, marking a significant milestone [10] - The company has streamlined its organizational structure following two divestitures earlier in 2025, leading to a 12% reduction in SG&A expenses [20][21] Q&A Session Summary Question: What are the priorities for increasing Integrity utilization? - Management indicated a balanced focus on acquiring new surgeons and training existing ones to drive utilization [29][31] Question: What is the timeline for Cingal bioequivalents and toxicity studies? - Management stated that the timeline will be clearer after the bioequivalent study begins, expected by the end of the year [32] Question: How does the company prioritize capital deployment? - The hierarchy includes internal investments in product growth, CapEx for manufacturing support, and share repurchase, with M&A not currently prioritized [33][35] Question: Are production issues fully resolved? - Management confirmed that production issues were a hangover from earlier disruptions but are expected to be resolved by year-end [36] Question: What are the expectations for gross margin in Q4? - Management indicated that gross margin in Q4 is expected to be between current levels and slightly higher, depending on recovery from shipping dynamics [37]

Financial Performance - Commercial Channel Revenue increased by 22% year-over-year[8] - OEM Revenue decreased by 20% due to lower pricing both in transfer units and royalties on Monovisc® and Orthovisc® sales controlled by J&J MedTech[12, 14] - Total Revenue decreased by 6% to $278 million[12, 14] - Gross Profit decreased due to lower OEM Channel revenue and higher manufacturing costs[14] - SG&A expenses decreased by 12% reflecting cost discipline[8, 12] - Adjusted EBITDA was $09 million[8] - Cash provided by operations totaled $69 million[8] Product and Pipeline Updates - Regenerative Solutions portfolio grew 25% year-over-year[8] - International OA Pain business grew 21% year-over-year[8] - Integrity Implant System continues to outpace the market with approximately 500 cases in Q3[8, 11] - Hyalofast® PMA was submitted on October 31, supported by U S Phase III data[8] Strategic Initiatives - Commenced a $15 million 10b5-1 share repurchase program[8]

Core Insights - Anika Therapeutics reported a 6% decrease in total revenue for Q3 2025, amounting to $27.8 million compared to the same period in 2024, while Commercial Channel revenue increased by 22% year over year [2][14] - The company reaffirmed its fiscal 2025 guidance and announced a $15 million share repurchase program [1][10] Financial Performance - Revenue from continuing operations was $27.8 million, down 6% from $29.6 million in Q3 2024 [2][14] - OEM Channel revenue decreased by 20% to $15.8 million, attributed to lower U.S. pricing for Monovisc and Orthovisc [2][14] - Commercial Channel revenue increased to $12.0 million, reflecting a 22% year-over-year growth [2][14] - Gross margin stood at 56%, with operating expenses down 3% to $18.8 million [14] Product Performance - Integrity procedures grew for the sixth consecutive quarter, with a projected doubling of procedures and revenue in 2025 compared to 2024 [4] - Cingal achieved a commercial milestone of over one million injections globally since its launch in 2016 [1][3] - International OA Pain Management revenue grew by 21% year over year, driven by distributor orders [5] Regulatory and Clinical Developments - Anika submitted the third and final module of the Hyalofast PMA application to the FDA, with positive clinical data released from the Phase III FastTRACK trial [6] - Progress was made towards filing the NDA for Cingal, with key activities including the completion of a toxicity study [7] Shareholder Returns - The company is commencing a $15 million 10b5-1 share repurchase program, expected to be completed by June 2026 [10]

Core Insights - Anika Therapeutics has filed the third and final module of its Premarket Approval application for Hyalofast, a hyaluronic acid-based scaffold for treating knee cartilage defects [1][2] - The company reported results from the U.S. pivotal Phase III FastTRACK clinical trial, which evaluated the efficacy of Hyalofast [3] Clinical Trial Overview - The FastTRACK study, initiated in 2015, was a randomized, active treatment-controlled trial designed to establish the superiority of Hyalofast combined with BMAC over microfracture, the standard of care at the time [4] - The study enrolled patients with symptomatic cartilage lesions and monitored outcomes for two years [4] Primary Endpoints Results - The study did not meet its pre-specified co-primary endpoints; KOOS Pain scores showed an 8.11% difference favoring microfracture (p=0.81), while IKDC Function scores showed a 4.84% difference favoring Hyalofast (p=0.34) [5] - High variability in baseline scores, particularly in the microfracture arm, influenced these results [5] Post-Hoc Analysis - A post-hoc analysis without imputation showed Hyalofast demonstrated a 23.37% improvement over microfracture in KOOS Pain score (p=0.02) and an absolute difference of 4.54 points (p=0.02) [6] Secondary Endpoints Results - Hyalofast showed statistically significant improvements in key secondary endpoints, including a 12.19-point gain in KOOS Sports and Recreation scores (p=0.01) and a 9.52-point improvement in KOOS Quality of Life scores (p=0.03) [7] - Total KOOS, a composite measure of pain and function, improved by 6.57 points (p=0.02) compared to microfracture [7] Responder Analysis - A responder analysis indicated that 87.4% of Hyalofast patients achieved at least a 10-point improvement in KOOS Pain compared to 75.3% of microfracture patients (p=0.050) [9] - At higher thresholds, Hyalofast patients showed even greater advantages, with 72.8% achieving a 20-point improvement compared to 52.6% in the microfracture group (p=0.029) [9] Clinical and Regulatory Implications - Despite not meeting pre-specified co-primary endpoints, the company remains confident in Hyalofast's clinical value, citing significant improvements in secondary endpoints [10] - Anika has treated over 35,000 patients globally with Hyalofast since 2009, reporting positive long-term outcomes [10] Product Information - Hyalofast is an off-the-shelf, single-stage scaffold designed to support the regeneration of hyaline-like cartilage and is marketed in over 35 countries [11]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Anika Therapeutics, Inc. for possible violations of federal securities laws and unlawful business practices affecting stockholders [1]. Investigation Details - The investigation is focused on whether Anika has engaged in any unlawful activities that may have led to financial losses for its investors [2]. Stock Price Impact - Following the announcement of the clinical trial results for Hyalofast, Anika's stock price dropped by $3.06 per share, representing a decline of 27.42%, closing at $8.10 per share on July 30, 2025 [6]. - The clinical trial did not meet its pre-specified co-primary endpoints, which was attributed to a higher dropout rate and missed visits during COVID, complicating the statistical analysis [6]. Next Steps for Investors - Investors who purchased Anika shares and suffered losses are encouraged to contact Bragar Eagel & Squire for more information regarding their rights and potential claims [3]. About the Law Firm - Bragar Eagel & Squire, P.C. is a nationally recognized law firm that represents individual and institutional investors in various types of litigation across the United States [4].

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Anika Therapeutics, Inc. for possible violations of federal securities laws and unlawful business practices affecting stockholders [1][2]. Investigation Details - The investigation is focused on whether Anika has engaged in unlawful practices that may have led to financial losses for investors [1][2]. - Anika's stockholders who have suffered losses are encouraged to contact the law firm for further discussion on their legal rights [3]. Company Background - Bragar Eagel & Squire, P.C. is a nationally recognized law firm with a focus on representing individual and institutional investors in complex litigation across various courts in the U.S. [4]. Recent Company Events - On July 30, 2025, Anika announced topline results from a pivotal clinical trial of Hyalofast, which did not meet its pre-specified co-primary endpoints, leading to a significant drop in stock price [6]. - Following the announcement, Anika's stock price fell by $3.06 per share, or 27.42%, closing at $8.10 per share [6].

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Anika Therapeutics, Inc. for possible violations of federal securities laws and unlawful business practices, following a significant drop in stock price after the announcement of clinical trial results for Hyalofast [1][3]. Group 1: Company Overview - Anika Therapeutics, Inc. (NASDAQ: ANIK) is involved in the development of medical products, including Hyalofast, a resorbable hyaluronic acid scaffold for cartilage repair [3]. - The company recently announced topline results from a pivotal clinical trial, which indicated that while Hyalofast showed improvements in treated patients, it did not meet its pre-specified co-primary endpoints [3]. Group 2: Stock Performance - Following the announcement of the clinical trial results, Anika's stock price fell by $3.06 per share, representing a decline of 27.42%, closing at $8.10 per share on July 30, 2025 [3]. Group 3: Legal Investigation - Bragar Eagel & Squire, P.C. is encouraging investors who suffered losses due to the stock price decline to contact them to discuss their legal rights and options [1][4]. - The investigation is focused on whether Anika's actions may have constituted violations of federal securities laws [1].