Part I: Financial Information [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Anika Therapeutics, Inc.'s unaudited condensed consolidated financial statements as of June 30, 2025, reflect decreased total assets and a net loss of $8.8 million for the six months [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $187.7 million, primarily due to divestitures, with liabilities and equity also declining Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$187,682** | **$202,740** | | Total Current Assets | $99,317 | $113,652 | | Cash and cash equivalents | $53,167 | $55,629 | | Assets held for sale | $- | $7,152 | | **Total Liabilities** | **$40,010** | **$48,751** | | Total Current Liabilities | $16,081 | $23,306 | | Liabilities held for sale | $- | $4,781 | | **Total Stockholders' Equity** | **$147,672** | **$153,989** | [Condensed Consolidated Statement of Operations and Comprehensive Income (Loss)](index=5&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) For the six months ended June 30, 2025, revenue decreased 9% to $54.4 million, gross profit fell 26%, and the company reported a net loss of $8.8 million Statement of Operations Summary (in thousands, except per share data) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $54,387 | $59,746 | | Gross Profit | $29,044 | $39,464 | | Loss from operations | $(8,464) | $(4,315) | | Loss from continuing operations | $(8,605) | $(4,497) | | Net loss | $(8,843) | $(4,602) | | Diluted EPS | $(0.62) | $(0.31) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Total stockholders' equity decreased to $147.7 million as of June 30, 2025, primarily due to a net loss and common stock repurchases - Key activities impacting stockholders' equity in the first six months of 2025 included a net loss of **$8.8 million** and the repurchase of common stock for **$4.0 million**[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities was $0.3 million, with investing activities providing $1.1 million, leading to a $4.0 million cash decrease Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(319) | $(1,195) | | Net cash provided by (used in) investing activities | $1,133 | $(5,211) | | Net cash used in financing activities | $(5,259) | $(3,384) | | **Decrease in cash and cash equivalents** | **$(3,992)** | **$(10,045)** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes highlight the company's strategic shift to OA Pain Management and Regenerative Solutions, recent divestitures, revenue concentration, and a $40.0 million share repurchase program - The company has strategically shifted to focus on its OA Pain Management and Regenerative Solutions businesses, resulting in the sale of Arthrosurface in October 2024 and Parcus Medical in March 2025[25](index=25&type=chunk)[32](index=32&type=chunk) - The company's sole significant customer, J&J MedTech, accounted for **50%** of total revenue for the six months ended June 30, 2025, down from **57%** in the same period of 2024[54](index=54&type=chunk) - In May 2024, the company implemented a share repurchase program for an aggregate of **$40.0 million**. As of June 30, 2025, **$15.0 million** of this program was completed[78](index=78&type=chunk)[79](index=79&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the 9% revenue decline to lower OEM Channel sales and contracted gross margin, with operating expenses decreasing 14%, aligning with the company's strategic focus [Management Overview](index=25&type=section&id=Management%20Overview) The company has repositioned as a global joint preservation company focused on OA Pain Management and Regenerative Solutions, driven by HA technology and new product launches after divestitures - The company announced a strategic shift in October 2024 to focus on its OA Pain Management and Regenerative Solutions businesses, leading to the sale of Arthrosurface and Parcus Medical[87](index=87&type=chunk) - Future success is expected to be driven by over 30 years of experience in HA-based solutions, with a focus on bringing key products like Cingal and Hyalofast to the U.S. market upon FDA approval[87](index=87&type=chunk)[92](index=92&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) For the six months ended June 30, 2025, revenue decreased 9% to $54.4 million, gross profit fell 26%, and the loss from operations nearly doubled to $8.5 million Revenue by Channel (in thousands) | Channel | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | % Change | | :--- | :--- | :--- | :--- | | OEM Channel | $31,249 | $38,337 | (18%) | | Commercial Channel | $23,138 | $21,409 | 8% | | **Total Revenue** | **$54,387** | **$59,746** | **(9%)** | - The decrease in OEM Channel revenue was primarily due to a **$7.1 million** reduction in J&J MedTech revenue, attributed to lower sales volumes (**$2.9 million**) and lower pricing (**$4.2 million**)[96](index=96&type=chunk) - Gross margin decreased to **53%** for the first six months of 2025 from **66%** in 2024, due to higher inventory reserves, increased manufacturing costs, and a higher percentage of lower-priced international sales[99](index=99&type=chunk) - SG&A expenses decreased primarily due to **$2.4 million** in non-recurring shareholder activism costs incurred in the first half of 2024[103](index=103&type=chunk) [Non-GAAP Financial Measures](index=31&type=section&id=Non-GAAP%20Financial%20Measures) Adjusted EBITDA for the six months ended June 30, 2025, was negative $0.2 million, a sharp decline from $7.4 million in 2024, driven by lower gross profit Adjusted EBITDA Reconciliation (in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net loss from continuing operations | $(8,605) | $(4,497) | | Adjustments | $8,427 | $11,896 | | **Adjusted EBITDA** | **$(178)** | **$7,409** | Adjusted Diluted EPS Reconciliation | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Diluted loss from continuing operations per share (EPS) | $(0.60) | $(0.30) | | Adjustments per share | $0.43 | $0.67 | | **Adjusted diluted (loss) income from continuing operations per share (EPS)** | **$(0.17)** | **$0.37** | [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held $53.2 million in cash and $83.2 million in working capital, with $0.3 million cash used in operations and an undrawn $75.0 million credit line - The company holds **$53.2 million** in cash and cash equivalents as of June 30, 2025[118](index=118&type=chunk) - Cash from investing activities was positive **$1.1 million** due to the **$4.5 million** received from the sale of Parcus Medical, which offset **$4.3 million** in capital expenditures[122](index=122&type=chunk) - The company has access to a **$75.0 million** senior revolving line of credit, which was undrawn as of June 30, 2025[119](index=119&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes occurred in the company's market risks or their management during the first six months of 2025 compared to the 2024 Form 10-K disclosures - There have been no material changes in the first six months of 2025 to the company's market risks or its management of such risks[128](index=128&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that as of June 30, 2025, the company's disclosure controls and procedures are effective[130](index=130&type=chunk) - No material changes were made to the internal control over financial reporting during the quarter ended June 30, 2025[131](index=131&type=chunk) Part II: Other Information [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal proceedings but does not expect their resolution to materially affect its financial position, operations, or cash flow - The company does not expect the resolution of occasional legal proceedings to have a material adverse effect on its financial position, results of operations, or cash flow[132](index=132&type=chunk) [Item 1A. Risk Factors](index=37&type=page&id=Item%201A.%20Risk%20Factors) A new risk factor highlights the failure of Hyalofast's U.S. pivotal Phase III trial in July 2025, potentially impacting FDA approval and future financial results - A new risk factor highlights that the U.S. pivotal FastTRACK Phase III trial of Hyalofast failed to achieve its pre-specified co-primary endpoints in July 2025[134](index=134&type=chunk) - The trial failure could materially negatively impact or delay the ability to obtain FDA regulatory approval for Hyalofast, which would have a material adverse effect on future revenue and financial results[134](index=134&type=chunk)[135](index=135&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company completed $15.0 million of its $40.0 million share repurchase program by June 30, 2025, with no repurchases made during the quarter - As of June 30, 2025, the company had repurchased **746,431 shares** for a total cost of **$15.0 million** under its 2024 Share Repurchase Program[136](index=136&type=chunk) - No share repurchases were made during the quarter ended June 30, 2025[136](index=136&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted or terminated Rule 10b5-1 trading plans during the quarter ended June 30, 2025 - No directors or executive officers adopted or terminated Rule 10b5-1 trading plans during the fiscal quarter ended June 30, 2025[140](index=140&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents, incentive plans, CEO/CFO certifications, and XBRL data

Financial Data and Key Metrics Changes - Total revenue for the second quarter was $28.2 million, an 8% decline compared to the same period in 2024 [21] - Adjusted EBITDA from continuing operations was negative $200,000, a decline of $4.9 million compared to the same period in 2024 [28] - Gross margin for the second quarter was 51%, down 16 percentage points from the same period last year, primarily due to a one-time $3 million charge related to lower yields [25][26] Business Line Data and Key Metrics Changes - Regenerative solutions revenue grew 41% year over year, driven by the Integrity Implant System [18][22] - Revenue in the OEM channel declined 13% to $16.3 million, reflecting continued pressure on demand and pricing for OrthoVisc and lower pricing for MONOVisc [23] - International OA pain sales experienced a 10% decline, primarily due to unfilled orders stemming from lower yields [22] Market Data and Key Metrics Changes - The U.S. augmentation market remains primarily driven by the shoulder, but there is meaningful traction in other areas such as the hip, knee, and ankle, representing over $40 million in addressable market opportunity [16] - Integrity has achieved sequential growth for five consecutive quarters and is on track to more than double in 2025 [22] Company Strategy and Development Direction - The company plans to submit the third and final PMA module for HYALOFAST in the second half of the year, with an extended commercial timeline to 2027 [13][14] - The company is focused on leveraging proprietary hyaluronic acid technologies and has streamlined its organizational structure to align with future growth [28][19] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the key value drivers of the business, particularly the performance of Integrity and the anticipated double-digit organic growth in the commercial channel [35] - Despite the HYALOFAST trial not meeting its primary endpoints, management believes the totality of the data supports a viable path to FDA approval [35][44] Other Important Information - The company ended the second quarter with $53 million in cash and no debt, maintaining strong liquidity [30] - The company has successfully completed divestitures of Parkis and Arthrosurface, allowing for a focused strategy on core products [19] Q&A Session Summary Question: What will drive the sequential improvement in gross margin? - Management indicated that the sequential improvement is expected due to the resolution of one-time charges and improved performance excluding those impacts [38][39] Question: Any progress on additional OEM partnerships? - Management stated that there are no new updates on additional OEM partnerships but continues to assess opportunities [40][41] Question: How should the market opportunity for Integrity be viewed with new configurations? - Management expressed optimism about the expanded market opportunity with new shapes and sizes for Integrity, which are expected to enhance market penetration [42][43] Question: What gives confidence for FDA approval of HYALOFAST despite missed primary endpoints? - Management noted that the FDA has encouraged submission of the full data package, including secondary endpoints that achieved statistical significance [44][45] Question: How should gross margin be viewed as the commercial channel grows? - Management indicated that while the commercial channel may have lower gross margins, new products like Integrity and HYALOFAST are expected to be accretive to gross margin [50][52] Question: Will cash flow improve going forward? - Management expects improvements in operating cash flow, although capital expenditures may impact cash balance [55][56] Question: Will capacity be sufficient to meet demand for new products? - Management indicated that continued investments will be necessary to meet future demand for Integrity, CINGAL, and HYALOFAST [57][58] Question: Any updates on the HYALOFAST trial's patient data? - Management confirmed that the study had a target of 200 patients, but dropout rates were higher in the microfracture arm, impacting the data set [62][63]

Anika Therapeutics (ANIK) came out with a quarterly loss of $0.13 per share in line with the Zacks Consensus Estimate. This compares to earnings of $0.17 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this medical technology company would post earnings of $0.09 per share when it actually produced a loss of $0.06, delivering a surprise of -166.67%. Over the last four quarters, the company has not been able to surpass consensus EPS estimates. Anik ...

Financial Performance - Revenue decreased by 8% to $282 million in Q2 2025[9, 11], driven by a 13% decrease in OEM revenue[9, 11] - Commercial Channel revenue was flat[11] - Gross profit decreased due to lower OEM channel revenue and higher manufacturing costs[11] - R&D expenses decreased primarily due to reduced headcount and lower spend associated with product development and regulatory activities[11] - SG&A expenses decreased due to a prior year one-time, non-recurring expense along with cost actions taken in the past year[11] - Adjusted EBITDA was $02 million[9] - Adjusted EPS was $(013)[9] Business Updates - Regenerative Solutions portfolio grew 41% year-over-year[8] - International OA Pain business grew 5% sequentially, but was down 10% year-over-year due to 2024 order timing and temporary production yield issues[8] - Integrity Implant System is exceeding launch expectations and outpacing the market, on pace to more than double in 2025[8] - Hyalofast FastTRACK study did not meet pre-specified co-primary endpoints for KOOS Pain and IKDC Function[6]

[Anika Second Quarter 2025 Financial Results](index=1&type=section&id=Anika%20Second%20Quarter%202025%20Financial%20Results) [Financial Performance](index=1&type=section&id=Financial%20Performance) 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 yields[14](index=14&type=chunk) - Operating expenses **decreased by 17% to $18.5 million**, reflecting successful progress on cost-saving measures[4](index=4&type=chunk)[14](index=14&type=chunk) [Revenue by Channel](index=1&type=section&id=Revenue%20by%20Channel) 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 MedTech[3](index=3&type=chunk) [Business & Operational Highlights](index=1&type=section&id=Business%20%26%20Operational%20Highlights) 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](index=1&type=section&id=Regenerative%20Solutions) 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 growth[2](index=2&type=chunk)[4](index=4&type=chunk) - The Integrity Implant System has already surpassed its full-year 2024 performance and is on track to **more than double in 2025**[2](index=2&type=chunk) - 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-end[5](index=5&type=chunk) [OA Pain Management](index=1&type=section&id=OA%20Pain%20Management) 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 issues[4](index=4&type=chunk)[6](index=6&type=chunk) - 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 2026[4](index=4&type=chunk) - 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 year[9](index=9&type=chunk) [Clinical & Corporate Updates](index=1&type=section&id=Clinical%20%26%20Corporate%20Updates) 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 endpoints[2](index=2&type=chunk)[8](index=8&type=chunk) - 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 Europe[2](index=2&type=chunk)[4](index=4&type=chunk)[8](index=8&type=chunk) - Production yield issues have been resolved, and all material transitional services for the **divestitures of Arthrosurface and Parcus Medical are complete**[10](index=10&type=chunk)[11](index=11&type=chunk) [Financial Guidance](index=2&type=section&id=Financial%20Guidance) 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](index=2&type=section&id=Fiscal%202025%20Guidance) 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)](index=2&type=section&id=Long-Term%20Outlook%20(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 Hyalofast**[2](index=2&type=chunk) - 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 2027[14](index=14&type=chunk)[15](index=15&type=chunk) - The company assumes **$3 million of initial sales for Hyalofast in 2027**[15](index=15&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) 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](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) 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](index=5&type=section&id=Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Measures) 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 compensation[31](index=31&type=chunk) - **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 period[33](index=33&type=chunk) - **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 2024[37](index=37&type=chunk)

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]

Core Insights - Anika Therapeutics announced topline results from its pivotal clinical trial of Hyalofast, a hyaluronic acid scaffold for cartilage repair, which showed improvements over microfracture but did not meet the pre-specified co-primary endpoints [2][4][6] - The company plans to file the final PMA module for Hyalofast in the second half of 2025, including additional analyses and data from independent studies conducted outside the U.S. [5][7] Clinical Trial Results - The FastTRACK study aimed to establish the superiority of Hyalofast with autologous BMAC over microfracture, with co-primary endpoints focused on KOOS pain and IKDC function scores [3] - Although Hyalofast showed consistent improvements in pain and function measures, it did not achieve statistical significance for the co-primary endpoints due to higher dropout rates and missed visits during COVID [4][6] Safety and Effectiveness - Hyalofast demonstrated statistically significant improvements in secondary endpoints, including KOOS Sports and Recreation Function and Quality of Life, supporting its safety and effectiveness profile [5][6] - The product has been used to treat over 35,000 patients in more than 35 countries since its launch in 2009, with positive long-term outcomes reported [5][8] Regulatory Plans - Anika plans to submit the third and final PMA module in H2 2025, which will include ongoing post-hoc analyses and additional endpoints previously accepted by the FDA [7] - The FDA has designated Hyalofast as a breakthrough device, allowing for prioritized review and interaction [8]

Core Viewpoint - Anika Therapeutics, Inc. will release its second quarter 2025 financial results on July 30, 2025, followed by a conference call 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, leveraging expertise in hyaluronic acid and implant solutions [3]. - The company aims to provide minimally invasive products that enhance active living, particularly in high opportunity areas 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]. Conference Call Details - The conference call to discuss the financial results can be accessed via a toll-free domestic number or an international number, with a conference ID provided [2]. - A live audio webcast and presentation materials will be available on Anika's Investor Relations website, and the call will be archived for later access [2].

Revenue Performance - Revenue for the three-month period ended March 31, 2025 was $26.2 million, a decrease of $2.9 million, or 10%, compared to the same period in 2024[90]. - Revenue from the OEM Channel decreased by 23% for the three-month period ended March 31, 2025, primarily due to lower pricing and sales to J&J MedTech[92]. - Revenue from the Commercial Channel increased by 18% for the three-month period ended March 31, 2025, driven by higher international sales of OA Pain Management products[93]. Profitability - Gross profit for the three-month period ended March 31, 2025 decreased by $4.3 million to $14.7 million, representing a gross margin of 56%, down from 65% in the prior year[94]. - Adjusted EBITDA for the three-month period ended March 31, 2025, decreased by $2.6 million to $127,000 compared to $2.7 million in the same period in 2024, primarily due to a decrease in OEM Channel revenues and lower gross profit[104]. - Adjusted net loss for the three-month period ended March 31, 2025, was $(895,000), a decrease of $2.8 million compared to adjusted net income of $1.9 million in the same period in 2024[106]. - Adjusted diluted loss per share for the three-month period ended March 31, 2025, was $(0.06), a decrease of $0.19 compared to adjusted diluted earnings per share of $0.13 in the same period in 2024[107]. - Loss from continuing operations for the three-month period ended March 31, 2025 was $4.0 million, compared to a loss of $2.0 million for the same period in 2024[97]. Expenses - Research and development expenses for the three-month period ended March 31, 2025 were $6.1 million, a decrease of $0.3 million compared to the same period in 2024[95]. - Selling, general and administrative expenses for the three-month period ended March 31, 2025 were $12.9 million, a decrease of $2.2 million compared to the same period in 2024[96]. Cash Flow and Liquidity - Cash and cash equivalents totaled $53.4 million as of March 31, 2025, down from $55.6 million at December 31, 2024[108]. - Cash used in operating activities was $(130,000) for the three-month period ended March 31, 2025, compared to $(126,000) in the same period in 2024[110]. - Cash provided by investing activities was $1.7 million for the three-month period ended March 31, 2025, compared to cash used of $(1.8 million) in the same period in 2024, primarily due to proceeds from the sale of Parcus Medical[112]. - Cash used in financing activities increased to $(5.4 million) for the three-month period ended March 31, 2025, compared to $(2.3 million) in the same period in 2024, mainly due to a $4.0 million share repurchase program[113]. - Working capital decreased to $84.6 million as of March 31, 2025, from $90.3 million at December 31, 2024[108]. - The company has no outstanding borrowings under its $75.0 million revolving line of credit as of March 31, 2025[109]. - The company anticipates an increase in cash requirements to fund operating activities and capital expenditures as operations expand[108]. Strategic Initiatives - The company announced a strategic shift to focus on OA Pain Management and Regenerative Solutions, involving the sale of Arthrosurface in October 2024 and Parcus Medical in March 2025[86]. - Cingal, a novel OA Pain Management product, is designed to provide pain relief for at least six months and is currently sold in over 35 countries[87]. - The Integrity Implant System, launched in 2024, is part of the company's growth strategy in the regenerative solutions market[89].

Company Performance - Anika Therapeutics reported a quarterly loss of $0.06 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.09, representing an earnings surprise of -166.67% [1] - The company posted revenues of $26.17 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 8.50%, and a significant decline from year-ago revenues of $40.52 million [2] - Over the last four quarters, Anika has not surpassed consensus EPS estimates and has topped consensus revenue estimates only twice [2] Stock Outlook - Anika shares have declined approximately 10.5% since the beginning of the year, compared to a decline of -3.7% for the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is $0.08 on revenues of $28.23 million, and for the current fiscal year, it is $0.31 on revenues of $113 million [7] - The estimate revisions trend for Anika is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Anika belongs, is currently in the top 32% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Anika's stock performance [5]