Anika Second Quarter 2025 Financial Results Financial Performance The company reported a Q2 2025 revenue of $28.2 million, an 8% decrease year-over-year, with a net loss from continuing operations of $4.6 million | Financial Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $28.2M | $30.7M | -8% | | Gross Profit | $14.4M | $20.5M | -30% | | Loss from Operations | ($4.2M) | ($1.8M) | -131% | | Loss from Continuing Operations | ($4.6M) | ($2.5M) | -83% | | Adjusted EBITDA | ($0.2M) | $4.7M | -104% | | Diluted Loss Per Share (Continuing Ops) | ($0.33) | ($0.17) | -94% | - Gross margin for the quarter was 51%, which included $3.0 million of inventory obsolescence and scrap charges related to lower production yields14 - Operating expenses decreased by 17% to $18.5 million, reflecting successful progress on cost-saving measures414 Revenue by Channel Commercial Channel revenue remained flat while OEM Channel revenue declined 13% due to lower product pricing | Revenue Channel | Q2 2025 | Q2 2024 | % Change | | :--- | :--- | :--- | :--- | | OEM Channel | $16,340K | $18,887K | -13% | | Commercial Channel | $11,879K | $11,837K | 0% | | Total Revenue | $28,219K | $30,724K | -8% | - The decline in OEM Channel revenue was driven by lower pricing for Monovisc and Orthovisc, sold by commercial partner J&J MedTech3 Business & Operational Highlights Regenerative Solutions grew strongly, but the Hyalofast U.S. clinical trial did not meet its primary endpoints, though progress continues on key initiatives Regenerative Solutions Revenue grew 41% driven by the Integrity Implant System, which also received expanded FDA 510(k) clearance - Regenerative Solutions revenue increased by 41% in the quarter, driven by Integrity's outperformance and strong International Hyalofast growth24 - The Integrity Implant System has already surpassed its full-year 2024 performance and is on track to more than double in 20252 - Anika received FDA 510(k) clearance for new Integrity implant shapes and sizes, targeting Achilles repair and other larger tendon applications, with a limited U.S. release planned by year-end5 OA Pain Management International revenue declined due to order timing and production issues, while the company advances its Cingal NDA filing - International OA Pain Management revenue declined 10% YoY in Q2 but was flat for the first half of 2025, attributed to 2024 order timing and temporary production yield issues46 - U.S. OA Pain Management pricing rebounded in Q2 but a more pronounced decline is anticipated in the second half of 2025, with normalization expected in 20264 - Anika is advancing key activities for the Cingal NDA filing, including ongoing toxicity studies and preparations for a bioequivalence study planned to start later this year9 Clinical & Corporate Updates The Hyalofast U.S. trial missed primary endpoints, but an FDA submission is still planned for the second half of 2025 - The Hyalofast U.S. Phase III clinical trial did not meet its pre-specified co-primary endpoints, but demonstrated statistically significant improvements in secondary endpoints28 - Despite the trial results, Anika plans to file the final PMA module for Hyalofast in the second half of 2025, based on the overall data and extensive real-world use in Europe248 - Production yield issues have been resolved, and all material transitional services for the divestitures of Arthrosurface and Parcus Medical are complete1011 Financial Guidance The company reaffirmed its 2025 guidance but revised its long-term outlook to reflect a potential delay in the U.S. launch of Hyalofast Fiscal 2025 Guidance The company is maintaining its full-year 2025 guidance for revenue and Adjusted EBITDA | 2025 Guidance Metric | Range | Year-over-Year Change | | :--- | :--- | :--- | | Commercial Channel Revenue | $47M - $49.5M | +12% to +18% | | OEM Channel Revenue | $62M - $65M | -16% to -20% | | Adjusted EBITDA | -3% to 3% | N/A | Long-Term Outlook (2026-2027) Long-term Commercial Channel growth guidance was lowered to +10% to +20% due to the anticipated Hyalofast launch delay to 2027 - The company revised its long-term outlook to reflect the potential timing of the FDA review for Hyalofast2 - Commercial Channel growth guidance for 2026 and 2027 was lowered from +20% to +30% down to +10% to +20%, anticipating the Hyalofast launch is now in 20271415 - The company assumes $3 million of initial sales for Hyalofast in 202715 Financial Statements This section presents the unaudited consolidated statements of operations, balance sheets, and non-GAAP reconciliations for the period ended June 30, 2025 Consolidated Statements of Operations The company reported a Q2 2025 net loss of $4.0 million on revenue of $28.2 million | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $28,219 | $30,724 | | Gross Profit | $14,363 | $20,489 | | Loss from operations | ($4,180) | ($1,810) | | Loss from continuing operations | ($4,647) | ($2,541) | | Net loss | ($3,970) | ($88) | Consolidated Balance Sheets As of June 30, 2025, the company held $53.2 million in cash and cash equivalents and $187.7 million in total assets | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $53,167 | $55,629 | | Total current assets | $99,317 | $113,652 | | Total assets | $187,682 | $202,740 | | Total current liabilities | $16,081 | $23,306 | | Total stockholders' equity | $147,672 | $153,989 | Reconciliation of GAAP to Non-GAAP Measures Q2 2025 GAAP net loss from continuing operations of $4.6 million reconciled to an Adjusted EBITDA of ($0.2) million - For Q2 2025, Adjusted EBITDA was ($188) thousand, a significant decrease from $4,685 thousand in Q2 2024, with the reconciliation from GAAP net loss including adjustments for taxes, D&A, and stock-based compensation31 - Adjusted net loss from continuing operations for Q2 2025 was ($1,661) thousand, compared to an adjusted net income of $610 thousand in the prior year period33 - Adjusted diluted net loss per share for Q2 2025 was ($0.13), compared to an adjusted diluted net income per share of $0.04 in Q2 202437
Anika Therapeutics(ANIK) - 2025 Q2 - Quarterly Results