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 reported a 41% increase in Regenerative Solutions revenue, driven by the strong performance of the Integrity Implant System and continued growth of Hyalofast, which is expected to double in 2025 [1][3] - The company reaffirmed its fiscal 2025 revenue and EBITDA guidance while revising its long-term outlook due to potential delays in the FDA review for Hyalofast [1][12] Financial Performance - For Q2 2025, Anika reported revenue of $28.2 million, an 8% decrease from Q2 2024, with OEM Channel revenue down 13% and Commercial Channel revenue flat year-over-year [2][13] - Operating expenses decreased by 17% to $18.5 million, contributing to a loss from continuing operations of $4.6 million, or $0.33 per share [13][24] Product Performance - The Integrity Implant System has shown consistent growth, with procedures increasing for five consecutive quarters, and new shapes and sizes expected to enhance market adoption [4] - Hyalofast's clinical trial results showed statistically significant improvements in secondary endpoints despite not meeting primary endpoints, with plans to submit the final PMA module to the FDA in the second half of 2025 [6][12] International Sales - International OA Pain Management revenue grew 5% sequentially but declined 10% year-over-year, attributed to order timing and production yield issues [5] - The company expects to resolve production yield issues by the end of Q3 2025, maintaining confidence in achieving full-year growth projections [5][8] Future Outlook - Anika anticipates a more pronounced decline in pricing for U.S. OA Pain Management products in the second half of 2025, with normalization expected in 2026 [3] - The company updated its long-term revenue guidance for 2026-2027, projecting a growth rate of 10% to 20% for the Commercial Channel, down from previous expectations of 20% to 30% [12]