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]

ANIKA, ANIKA THERAPEUTICS and the Anika logo are trademarks of Anika Therapeutics, Inc. or its subsidiaries or are licensed to Anika Therapeutics, Inc. for its use. For Investor Inquiries: Anika Therapeutics, Inc. Matt Hall, 781-457-9554 Director, Corporate Development and Investor Relations investorrelations@anika.com Webcast of the presentation and Q&A will be available in the Investor Relations section of Anika's website, www.anika.com. An archive of the presentation will also be available on the website ...