Revenue Performance - Revenue from the OEM Channel product family decreased by 20% for the three-month period and 19% for the nine-month period ended September 30, 2025, compared to the same periods in 2024, with a total decrease of $3.9 million and $11.0 million respectively [100]. - Revenue from the Commercial Channel product family increased by 22% for the three-month period and 13% for the nine-month period ended September 30, 2025, with international OA pain management product sales increasing by $1.5 million [101]. Profitability - Gross profit for the three- and nine-month periods ended September 30, 2025 was $15.6 million and $44.6 million, respectively, down from $19.4 million and $58.9 million in the same periods in 2024 [102]. - Gross margin decreased to 56% for the three-month period and 54% for the nine-month period ended September 30, 2025, compared to 66% for both periods in 2024 [103]. Expenses - Total research and development expenses for the three-month period ended September 30, 2025 were $5.9 million, a 17% decrease from $6.9 million in the same period in 2024 [105]. - Research and development external costs increased to $3.3 million for the three-month period ended September 30, 2025, up from $2.3 million in the same period in 2024 [106]. - Selling, general and administrative expenses decreased to $11.9 million for the three-month period ended September 30, 2025, down from $13.5 million in the same period in 2024 [107]. Losses - Loss from continuing operations increased to $3.2 million for the three-month period ended September 30, 2025, compared to a loss of $1.8 million in the same period in 2024 [108]. - Adjusted EBITDA for the three-month period ended September 30, 2025 was $865,000, a decrease of $3.7 million compared to $4.5 million in the same period in 2024 [116]. - Adjusted net loss for the nine-month period ended September 30, 2025 was $11.8 million, compared to a loss of $6.3 million in the same period in 2024 [118].

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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]

Core Insights - Anika Therapeutics reported quarterly earnings of $0.04 per share, exceeding the Zacks Consensus Estimate of $0.02 per share, compared to a loss of $0.25 per share a year ago, indicating a significant earnings surprise of +100.00% [1] - The company generated revenues of $27.82 million for the quarter ended September 2025, slightly surpassing the Zacks Consensus Estimate by 0.06%, but down from $38.75 million in the same quarter last year [2] - Anika's stock has underperformed, losing approximately 41.5% year-to-date, while the S&P 500 has gained 15.1% [3] Earnings Outlook - The future performance of Anika's stock will largely depend on management's commentary during the earnings call and the revisions of earnings estimates [3][4] - The current consensus EPS estimate for the upcoming quarter is $0.03 on revenues of $29.1 million, and for the current fiscal year, it is -$0.14 on revenues of $111.3 million [7] Industry Context - Anika operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 40% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - The correlation between near-term stock movements and earnings estimate revisions is strong, indicating that tracking these revisions can provide insights into stock performance [5][6]

Anika. Restore Active Living. SAFE HARBOR STATEMENTS Q3 2025 EARNINGS CALL NOVEMBER 5, 2025 The statements made in, and during the course of, this presentation that are not statements of historical fact, including those related to the Company's commercial capabilities, initiatives and production, its product pipeline and associated timelines, its upcoming corporate milestones, and its growth strategy and projections, are forward looking statements within the meaning of Section 27A of the Securities Act of 1 ...

Revenue Performance - Anika reported third quarter revenue from continuing operations of $27.8 million, a 6% decrease compared to the same period in 2024[3]. - Commercial Channel revenue increased 22% year over year to $12.0 million, while OEM Channel revenue decreased 20% to $15.8 million[3][17]. - Regenerative Solutions revenue in the Commercial Channel grew 25% in the quarter, driven by strong performance of the Integrity Implant System and international Hyalofast growth[4]. - International Sales revenue grew 21% year over year, contributing to a year-to-date revenue increase of 6%[6]. - Revenue for the three months ended September 30, 2025, was $27,817 million, a decrease of 6% from $29,559 million in the same period of 2024[25]. - The OEM Channel revenue decreased by 20% to $15,844 million for the three months ended September 30, 2025, compared to $19,764 million in 2024[36]. - The Commercial Channel revenue increased by 22% to $11,973 million for the three months ended September 30, 2025, compared to $9,795 million in 2024[36]. Financial Guidance - Anika maintains its fiscal 2025 revenue guidance, projecting Commercial Channel revenue of $47 to $49.5 million, up 12% to 18% year over year, and OEM Channel revenue of $62 to $65 million, down 16% to 20% year over year[12][17]. Operating Expenses - Operating expenses decreased by 3% year over year to $18.8 million, with Selling, General and Administrative expenses down 12%[4][17]. - Operating expenses totaled $18,817 million for the three months ended September 30, 2025, compared to $19,489 million in 2024, a decrease of 3%[25]. Profitability - Anika reported a loss from continuing operations of $3.2 million, or $0.22 per share, with adjusted net income of $0.7 million, or $0.04 per share[17]. - Gross profit for the three months ended September 30, 2025, was $15,584 million, down from $19,408 million in 2024, reflecting a decline of 20%[25]. - The net loss for the three months ended September 30, 2025, was $2,329 million, significantly improved from a net loss of $29,918 million in the same period of 2024[25]. - Adjusted EBITDA for the three months ended September 30, 2025, was $865 million, down from $4,542 million in 2024[29]. Asset and Liability Management - Total current assets as of September 30, 2025, were $101,590 million, down from $113,652 million as of December 31, 2024[27]. - Total liabilities as of September 30, 2025, were $42,632 million, compared to $48,000 million as of December 31, 2024[27]. - Stockholders' equity decreased to $146,805 million as of September 30, 2025, from $153,989 million as of December 31, 2024[27]. Regulatory and Strategic 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[7][8]. - The company is advancing towards filing the NDA for Cingal, with key activities including the completion of a toxicity study and initiation of a bioequivalence study[9]. - The company is commencing a $15 million 10b5-1 share repurchase program, expected to be completed by June 2026[13].

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]

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Core Insights - Anika Therapeutics, Inc. will release its third quarter 2025 financial results on November 5, 2025, before market opening, followed by a conference call at 8:30 a.m. ET to discuss the results and business highlights [1]. Company Overview - Anika Therapeutics, Inc. is a global joint preservation company focused on early intervention orthopedic care, specializing in hyaluronic acid and implant solutions [3]. - The company aims to provide minimally invasive products that enhance active living, targeting high opportunity areas in orthopedics such as Osteoarthritis Pain Management and Regenerative Solutions [3]. - Anika's operations are headquartered outside of Boston, Massachusetts, and its products are delivered efficiently in key care sites, including ambulatory surgery centers [3].