[PART I: FINANCIAL INFORMATION](index=3&type=section&id=Part%20I%20Financial%20Information) This section details Anika Therapeutics' unaudited condensed financial statements and management's analysis for the first quarter of 2024 [ITEM 1. FINANCIAL INFORMATION: CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)](index=3&type=section&id=Item%201.%20Financial%20Information%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29) This section presents Anika Therapeutics' unaudited condensed consolidated financial statements for Q1 2024, covering financial position, performance, and cash flows [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and equity at specific reporting dates Condensed Consolidated Balance Sheets (in thousands) | ASSETS (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $68,629 | $72,867 | | Accounts receivable, net | $32,077 | $35,961 | | Inventories, net | $49,408 | $46,386 | | Total current assets | $158,962 | $163,309 | | Total assets | $263,744 | $270,632 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $28,460 | $31,059 | | Total stockholders' equity | $208,536 | $212,265 | | Total liabilities and stockholders' equity | $263,744 | $270,632 | [Condensed Consolidated Statement of Operations and Comprehensive Income](index=4&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20and%20Comprehensive%20Income) This section outlines the company's financial performance, detailing revenue, expenses, and net loss for the reporting period Condensed Consolidated Statement of Operations and Comprehensive Income (in thousands, except per share data) | (in thousands, except per share data) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Revenue | $40,523 | $37,924 | | Gross Profit | $24,628 | $22,843 | | Total operating expenses | $29,691 | $35,396 | | Loss from operations | $(5,063) | $(12,553) | | Net loss | $(4,514) | $(10,350) | | Net loss per share: Basic | $(0.31) | $(0.71) | | Net loss per share: Diluted | $(0.31) | $(0.71) | | Comprehensive loss | $(4,886) | $(10,078) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) This section details changes in stockholders' equity, reflecting net loss, stock-based compensation, and other comprehensive loss Condensed Consolidated Statements of Stockholders' Equity (in thousands, except per share data) | (in thousands, except per share data) | Balance, Jan 1, 2024 | Balance, Mar 31, 2024 | | :------------------------------------ | :------------------- | :-------------------- | | Common Stock, $.01 Par Value | $147 | $148 | | Additional Paid in Capital | $90,009 | $91,165 | | Retained Earnings | $128,052 | $123,538 | | Accumulated Other Comprehensive Loss | $(5,943) | $(6,315) | | Total Stockholders' Equity | $212,265 | $208,536 | | **Key Changes (Q1 2024):** | | | | Stock-based compensation expense | | $3,430 | | Net loss | | $(4,514) | | Other comprehensive loss | | $(372) | - Total stockholders' equity decreased from **$212,265 thousand** at January 1, 2024, to **$208,536 thousand** at March 31, 2024, primarily due to a net loss of **$4,514 thousand** and other comprehensive loss of **$372 thousand**, partially offset by stock-based compensation expense of **$3,430 thousand**[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section reports cash inflows and outflows from operating, investing, and financing activities for the reporting period Condensed Consolidated Statements of Cash Flows (in thousands) | (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(126) | $(3,618) | | Net cash used in investing activities | $(1,808) | $(1,389) | | Net cash used in financing activities | $(2,273) | $(1,613) | | Decrease in cash and cash equivalents | $(4,238) | $(6,590) | | Cash and cash equivalents at end of period | $68,629 | $79,737 | - Net cash used in operating activities significantly decreased from **$3,618 thousand** in Q1 2023 to **$126 thousand** in Q1 2024, primarily due to a lower net loss[17](index=17&type=chunk)[110](index=110&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Nature of Business](index=7&type=section&id=1.%20Nature%20of%20Business) This section describes Anika Therapeutics' core business as a global joint preservation company and its strategic acquisitions - Anika Therapeutics, Inc. is a global joint preservation company focused on early intervention orthopedic care, including OA pain management, regenerative solutions, sports medicine, and Arthrosurface joint solutions[20](index=20&type=chunk) - The company expanded its technology platform and product portfolio in early 2020 through strategic acquisitions of Parcus Medical, LLC (sports medicine) and Arthrosurface, Inc. (joint replacement solutions), diversifying revenue and enhancing commercial capabilities[21](index=21&type=chunk) [2. Basis of Presentation](index=7&type=section&id=2.%20Basis%20of%20Presentation) This section outlines the accounting principles, consolidation scope, and segment reporting for the financial statements - The financial statements are unaudited, prepared in accordance with U.S. GAAP and SEC rules for interim statements, and include Anika Therapeutics, Inc. and its subsidiaries[23](index=23&type=chunk) - The company operates as a single operating and reportable segment[25](index=25&type=chunk) - New accounting pronouncements (ASU 2023-07 on Segment Reporting and ASU 2023-09 on Income Taxes) are effective for fiscal years beginning after December 15, 2024, and the Company is evaluating their impact[27](index=27&type=chunk)[28](index=28&type=chunk) [3. Accounts Receivable](index=8&type=section&id=3.%20Accounts%20Receivable) This section details the composition of accounts receivable and the allowance for credit losses Accounts Receivable (in thousands) | Accounts Receivable (in thousands) | March 31, 2024 | December 31, 2023 | | :--------------------------------- | :------------- | :---------------- | | Accounts Receivable | $33,735 | $37,580 | | Less: Allowance for credit losses | $1,658 | $1,619 | | Net balance, end of period | $32,077 | $35,961 | Allowance for Credit Losses Activity (in thousands) | Allowance for Credit Losses Activity (in thousands) | March 31, 2024 | March 31, 2023 | | :-------------------------------------------------- | :------------- | :------------- | | Balance, beginning of the period | $1,619 | $1,608 |\ | Amounts provided | $185 | $102 | | Amounts recovered | $(92) | $(78) | | Amounts written off | $(45) | $(106) | | Translation adjustments | $(9) | $11 | | Balance, end of period | $1,658 | $1,537 | [4. Fair Value Measurements](index=9&type=section&id=4.%20Fair%20Value%20Measurements) This section describes the valuation methods and hierarchy for financial instruments, particularly cash equivalents - Cash equivalents in money market funds are classified as **Level 1** in the fair value hierarchy, valued based on quoted prices in active markets[33](index=33&type=chunk) Cash Equivalents (in thousands) | Cash Equivalents (in thousands) | March 31, 2024 | December 31, 2023 | | :------------------------------ | :------------- | :---------------- | | Money Market Funds | $52,177 | $55,485 | [5. Inventories](index=9&type=section&id=5.%20Inventories) This section provides a breakdown of inventory components and associated reserves Inventories (in thousands) | Inventories (in thousands) | March 31, 2024 | December 31, 2023 | | :------------------------- | :------------- | :---------------- | | Raw materials | $16,264 | $15,507 | | Work-in-process | $17,264 | $17,002 | | Finished goods | $33,048 | $32,084 | | Total | $66,576 | $64,593 | | Inventories (net) | $49,408 | $46,386 | | Inventory reserves | $13,600 | $11,700 | [6. Intangible Assets](index=10&type=section&id=6.%20Intangible%20Assets) This section details the company's intangible assets, their net book value, and amortization schedule Intangible Assets (in thousands) | Intangible Assets (in thousands) | March 31, 2024 Net Book Value | December 31, 2023 Net Book Value | | :------------------------------- | :---------------------------- | :------------------------------- | | Developed technology | $1,800 | $1,973 | | IPR&D | $1,650 | $1,650 | | Customer relationships | $345 | $360 | | Patents | $71 | $83 | | Tradenames | $431 | $560 | | Total | $4,297 | $4,626 | - Aggregate amortization expense for intangible assets decreased significantly from **$1.9 million** in Q1 2023 to **$0.3 million** in Q1 2024[38](index=38&type=chunk) Scheduled Amortization of Intangible Assets (in thousands) | Scheduled Amortization of Intangible Assets (in thousands) | | :------------------------------------------------------- | | Remainder of 2024 | $1,008 | | 2025 | $274 | | 2026 | $160 | | 2027 | $160 | | 2028 | $160 | | Thereafter | $886 | | Total | $2,648 | [7. Goodwill](index=10&type=section&id=7.%20Goodwill) This section discusses the carrying value of goodwill and the company's impairment assessment policy - Goodwill is assessed for impairment annually or more frequently if circumstances indicate. The carrying value of goodwill was **$7,403 thousand** at March 31, 2024, down from **$7,571 thousand** at December 31, 2023, primarily due to foreign currency adjustments[5](index=5&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk) [8. Accrued Expenses and Other Current Liabilities](index=10&type=section&id=8.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This section itemizes the company's accrued expenses and other current liabilities at period-end Accrued Expenses and Other Current Liabilities (in thousands) | Accrued Expenses and Other Current Liabilities (in thousands) | March 31, 2024 | December 31, 2023 | | :------------------------------------------------------------ | :------------- | :---------------- | | Compensation and related expenses | $8,595 | $11,828 | | Professional fees | $3,434 | $3,240 | | Operating lease liability – current | $2,129 | $2,133 | | Discontinuation of software development project | $1,904 | $1,904 | | Income taxes payable | $1,490 | $1,240 | | Clinical trial costs | $249 | $460 | | Share based compensation | $160 | $- | | Other | $477 | $394 | | Total | $18,438 | $21,199 | [9. Commitments and Contingencies](index=11&type=section&id=9.%20Commitments%20and%20Contingencies) This section outlines the company's product warranties, indemnification obligations, and legal proceedings - The Company provides product warranties and indemnifies customers against intellectual property claims, but believes the fair value of these agreements is immaterial due to historical activity and liability insurance coverage[46](index=46&type=chunk) - The Company is involved in various legal proceedings in the normal course of business but does not expect their resolution to have a material adverse effect on its financial position, results of operations, or cash flow[48](index=48&type=chunk) [10. Revenue and Geographic Information](index=12&type=section&id=10.%20Revenue%20and%20Geographic%20Information) This section breaks down revenue by product family and geographic location, highlighting key customer contributions Revenue by Product Family (in thousands) | Revenue by Product Family (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--------------------------------------- | :-------------------------------- | :-------------------------------- | | OA Pain Management | $24,318 | $22,633 | | Joint Preservation and Restoration | $13,841 | $13,453 | | Non-Orthopedic | $2,364 | $1,838 | | Total | $40,523 | $37,924 | - Revenue from DePuy Synthes Mitek Sports Medicine, a significant customer, accounted for **42% of total revenue** in Q1 2024 (**43%** in Q1 2023)[50](index=50&type=chunk) Revenue by Geographic Location (in thousands) | Revenue by Geographic Location (in thousands) | Three Months Ended March 31, 2024 | Percentage of Revenue | Three Months Ended March 31, 2023 | Percentage of Revenue | | :-------------------------------------------- | :-------------------------------- | :-------------------- | :-------------------------------- | :-------------------- | | United States | $29,236 | 72% | $27,288 | 72% | | Europe | $5,969 | 15% | $5,662 | 15% | | Other | $5,318 | 13% | $4,974 | 13% | | Total | $40,523 | 100% | $37,924 | 100% | [11. Equity Incentive Plan](index=13&type=section&id=11.%20Equity%20Incentive%20Plan) This section details the company's equity incentive plans, available shares, and stock-based compensation expense - The 2017 Omnibus Incentive Plan was amended to increase available shares by **435,000** to **5,285,000**, with **0.7 million shares** available for future grant at March 31, 2024[54](index=54&type=chunk) - The 2021 Inducement Plan was amended to increase shares by **125,000** to **250,000**, with **0.1 million shares** available for future grant at March 31, 2024[55](index=55&type=chunk) Stock-based Compensation Expense (in thousands) | Stock-based Compensation Expense (in thousands) | March 31, 2024 | March 31, 2023 | | :---------------------------------------------- | :------------- | :------------- | | Cost of revenue | $127 | $184 | | Research and development | $531 | $517 | | Selling, general and administrative | $2,932 | $3,016 | | Total stock-based compensation expense | $3,590 | $3,717 | [12. Income Taxes](index=16&type=section&id=12.%20Income%20Taxes) This section explains the effective tax rate and its drivers, including the impact of valuation allowances - The effective tax rate for Q1 2024 was **(1.0%)** (immaterial expense), compared to **13.9% benefit** in Q1 2023. This change is primarily due to a full valuation allowance recorded against domestic deferred tax assets at March 31, 2024, reflecting prior year operating losses[68](index=68&type=chunk)[69](index=69&type=chunk) [13. Earnings Per Share ("EPS")](index=16&type=section&id=13.%20Earnings%20Per%20Share%20%28%22EPS%22%29) This section presents basic and diluted earnings per share, noting the anti-dilutive effect of potential common shares - Basic and diluted EPS were **$(0.31)** for Q1 2024 and **$(0.71)** for Q1 2023. Due to net losses, all potential common shares (stock options and RSUs) were anti-dilutive and excluded from diluted EPS calculations[11](index=11&type=chunk)[72](index=72&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of Anika's financial condition, operational results, and liquidity for Q1 2024 compared to the prior year [Management Overview](index=17&type=section&id=Management%20Overview) This section provides an overview of Anika Therapeutics' business strategy, focus on joint preservation, and future growth drivers - Anika Therapeutics is a global joint preservation company focused on early intervention orthopedic care, leveraging over **30 years of expertise** in hyaluronic acid (HA) technology[76](index=76&type=chunk) - Future success is expected to be driven by HA-based regenerative solutions, introduction of key HA-based products (Cingal, Hyalofast, Integrity) into the US market upon FDA approval, global commercial expansion, and strategic inorganic growth opportunities[78](index=78&type=chunk) [Products](index=18&type=section&id=Products) This section categorizes Anika Therapeutics' product portfolio, including OA Pain Management, Joint Preservation, and Non-Orthopedic solutions - OA Pain Management includes Monovisc, Orthovisc, and Cingal (a novel single-injection product sold outside the US, awaiting FDA approval after a successful Phase III trial)[79](index=79&type=chunk) - Joint Preservation and Restoration encompasses HA-based regenerative solutions (Integrity, Tactoset, Hyalofast), sports medicine solutions, and Arthrosurface bone-preserving joint technologies[81](index=81&type=chunk) - Non-Orthopedic products are legacy HA-based items for anti-adhesion, wound care, ENT, ophthalmic applications, and Hyvisc for equine OA[82](index=82&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, including revenue, gross profit, operating expenses, and net loss [Three Months Ended March 31, 2024 Compared to Three Months Ended March 31, 2023](index=20&type=section&id=Three%20Months%20Ended%20March%2031%2C%202024%20Compared%20to%20Three%20Months%20Ended%20March%2031%2C%202023) This section provides a detailed comparative analysis of financial results for the first quarter of 2024 versus 2023 Results of Operations (in thousands, except percentages) | (in thousands, except percentages) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change ($) | % Change | | :--------------------------------- | :-------------------------------- | :-------------------------------- | :--------- | :------- | | Revenue | $40,523 | $37,924 | $2,599 | 7% | | Cost of revenue | $15,895 | $15,081 | $814 | 5% | | Gross profit | $24,628 | $22,843 | $1,785 | 8% | | Gross margin | 61% | 60% | | | | Research and development | $8,164 | $8,400 | $(236) | (3%) | | Selling, general and administrative | $21,527 | $26,996 | $(5,469) | (20%) | | Total operating expenses | $29,691 | $35,396 | $(5,705) | (16%) | | Loss from operations | $(5,063) | $(12,553) | $7,490 | (60%) | | Net loss | $(4,514) | $(10,350) | $5,836 | (56%) | - Revenue increased **7% year-over-year** to **$40.5 million**, driven by growth across all product families: OA Pain Management (**+7%**), Joint Preservation and Restoration (**+3%**), and Non-Orthopedic (**+29%**)[84](index=84&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) - Net loss decreased by **56%** to **$4.5 million**, primarily due to higher revenues and a significant reduction in selling, general and administrative expenses (down **20%**) due to non-recurring costs in the prior year[84](index=84&type=chunk)[90](index=90&type=chunk)[92](index=92&type=chunk) [Non-GAAP Financial Measures](index=21&type=section&id=Non-GAAP%20Financial%20Measures) This section presents and reconciles non-GAAP financial measures used by management to assess operational performance - Management uses non-GAAP measures like adjusted gross profit, adjusted gross margin, adjusted EBITDA, adjusted net income, and adjusted EPS to evaluate operating performance and identify underlying business trends, excluding items such as amortization of acquired intangibles, inventory fair-value step-up, stock-based compensation, and acquisition-related expenses[93](index=93&type=chunk)[95](index=95&type=chunk)[96](index=96&type=chunk)[98](index=98&type=chunk)[102](index=102&type=chunk) Non-GAAP Metrics (in thousands, except EPS) | Non-GAAP Metrics (in thousands, except EPS) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Adjusted gross profit | $25,257 | $24,405 | | Adjusted gross margin | 62% | 64% | | Adjusted EBITDA | $2,502 | $(1,204) | | Adjusted net income (loss) | $1,240 | $(2,163) | | Adjusted diluted earnings (loss) per share | $0.09 | $(0.14) | - Adjusted EBITDA increased by **$3.7 million**, and Adjusted net income and Adjusted diluted EPS improved significantly, primarily due to higher revenues and lower spending following product launches and addressing regulatory requirements[101](index=101&type=chunk)[106](index=106&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, working capital, credit facilities, and cash flow activities - Cash and cash equivalents were **$68.6 million** at March 31, 2024, down from **$72.9 million** at December 31, 2023. Working capital totaled **$130.5 million**[107](index=107&type=chunk) - The Company has a **$75.0 million** senior revolving line of credit, with no outstanding borrowings as of March 31, 2024, and is in compliance with its terms[108](index=108&type=chunk) - Cash used in operating activities decreased significantly to **$0.1 million** in Q1 2024 from **$3.6 million** in Q1 2023, primarily due to a lower net loss[110](index=110&type=chunk) - Cash used in investing activities increased to **$1.8 million** in Q1 2024 (from **$1.4 million** in Q1 2023) due to increased capital expenditures for manufacturing operations[112](index=112&type=chunk) - Cash used in financing activities increased to **$2.3 million** in Q1 2024 (from **$1.6 million** in Q1 2023), mainly due to cash paid for employee tax withholding on vested restricted stock awards[113](index=113&type=chunk) [Critical Accounting Policies and Estimates](index=25&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section confirms no material changes to critical accounting policies and estimates from the prior annual report - No significant changes were made to critical accounting policies or underlying assumptions and estimates from those disclosed in the 2023 Form 10-K[114](index=114&type=chunk) [Recent Accounting Pronouncements](index=25&type=section&id=Recent%20Accounting%20Pronouncements) This section provides updates on recent accounting pronouncements and their potential impact on the company - A discussion of recent accounting pronouncements is updated in the Notes to the condensed consolidated financial statements[115](index=115&type=chunk) [Contractual Obligations and Other Commercial Commitments](index=25&type=section&id=Contractual%20Obligations%20and%20Other%20Commercial%20Commitments) This section confirms no material changes to contractual obligations and commercial commitments from the prior annual report - There were no material changes to contractual obligations reported in the 2023 Form 10-K during the three months ended March 31, 2024[116](index=116&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section confirms no material changes to the company's market risks or their management during Q1 2024 - No material changes to market risks or their management occurred in Q1 2024 compared to the disclosures in the 2023 Form 10-K[118](index=118&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures and internal controls over financial reporting [(a) Evaluation of disclosure controls and procedures.](index=26&type=section&id=%28a%29%20Evaluation%20of%20disclosure%20controls%20and%20procedures.) This section confirms the effectiveness of the company's disclosure controls and procedures as of March 31, 2024 - As of March 31, 2024, management, including the CEO and CFO, concluded that the company's disclosure controls and procedures are effective[120](index=120&type=chunk) [(b) Changes in internal controls over financial reporting.](index=26&type=section&id=%28b%29%20Changes%20in%20internal%20controls%20over%20financial%20reporting.) This section reports no material changes in internal control over financial reporting during the first quarter of 2024 - There were no material changes in internal control over financial reporting during the quarter ended March 31, 2024[121](index=121&type=chunk) [PART II: OTHER INFORMATION](index=26&type=section&id=Part%20II%20Other%20Information) This section provides additional information including legal proceedings, risk factors, equity sales, and exhibits [ITEM 1. LEGAL PROCEEDINGS](index=26&type=section&id=Item%201.%20Legal%20Proceedings) This section confirms no material changes to legal proceedings from the prior annual report, with no expected material adverse effects - No material changes to legal proceedings were reported in Q1 2024; the company does not expect current proceedings to materially affect its financial position[122](index=122&type=chunk) [ITEM 1A. RISK FACTORS](index=26&type=section&id=Item%201A.%20Risk%20Factors) This section confirms no material changes to the risk factors previously disclosed in the company's annual report - No material changes to risk factors were reported in Q1 2024 compared to the 2023 Form 10-K[123](index=123&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section updates on the share repurchase program and confirms no recent unregistered sales of equity securities - The company established a **$20.0 million** share repurchase program in April 2023, repurchasing **188,029 shares** at an average price of **$26.59 per share** during 2023[125](index=125&type=chunk) - There were no recent unregistered sales of equity securities[126](index=126&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=27&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities were reported[126](index=126&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES.](index=27&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This section states that mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable to the company[126](index=126&type=chunk) [ITEM 5. OTHER INFORMATION.](index=27&type=section&id=Item%205.%20Other%20Information.) This section provides other relevant information, specifically regarding Rule 10b5-1 trading plans - No directors or executive officers adopted or terminated Rule 10b5-1 trading plans during the fiscal quarter ended March 31, 2024[126](index=126&type=chunk) [ITEM 6. EXHIBITS](index=28&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including certifications and XBRL data - The report includes certifications (Rule 13a-14(a)/15d-14(a) and Section 1350) from Dr. Cheryl R. Blanchard and Michael Levitz, as well as XBRL formatted financial statements[128](index=128&type=chunk) [SIGNATURES](index=29&type=section&id=SIGNATURES) This section contains the official signatures certifying the accuracy and completeness of the Form 10-Q filing - The report was signed on behalf of Anika Therapeutics, Inc. by Michael Levitz, Executive Vice President, Chief Financial Officer and Treasurer, on May 8, 2024[130](index=130&type=chunk)

EXHIBIT 99.1 Anika Reports First Quarter 2024 Financial Results Revenue up 7% on growing demand and favorable order timing; On-track for 2024 revenue guidance Cost reduction initiatives complete; On-track to achieve 2024 adjusted EBITDA guidance of $25-30 million, up over 75% at the midpoint BEDFORD, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company in early intervention orthopedics, today reported financial results for its first quarter end ...

BEDFORD, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ:ANIK), a global joint preservation company in early intervention orthopedics, today announced that it has appointed Steve Griffin as the Company's Executive Vice President, Chief Financial Officer ("CFO") and Treasurer, effective June 3, 2024. He succeeds Michael Levitz, who has decided to step down as CFO after almost four years with the company. Mr. Levitz will remain with the Company through December 31, 2024, to ensure a s ...

BEDFORD, Mass., April 18, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ:ANIK), a global joint preservation company in early intervention orthopedics, today announced that the Company plans to issue its first quarter 2024 financial results after the close of the market on Wednesday, May 8, 2024 and hold its investor conference call on the same day, at 5:30 p.m. ET to discuss its financial results and business highlights. The conference call can be accessed by dialing 1-888-886-7786 (toll-free dom ...

BEDFORD, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ:ANIK), a global joint preservation company in early intervention orthopedics, today announced that management will participate in the 23rd Annual Needham Virtual Healthcare Conference on Monday, April 8, 2024. Anika will host a virtual presentation with Q&A starting at 2:15pm ET. 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 presen ...

Revenue Performance - Revenue for the year ended December 31, 2023, was $166.7 million, an increase of $10.5 million, or 7%, compared to the prior year[239]. - OA Pain Management revenue increased 11% to $101.9 million, driven by global sales growth of Monovisc and strong international growth of Cingal[240]. - Joint Preservation and Restoration revenue rose 9% to $54.9 million, attributed to the adoption of new products like X-Twist and higher international sales[240]. - Non-Orthopedic revenue decreased 29% to $9.9 million, primarily due to lower veterinary sales and reclassification of revenue reporting[242]. - Total revenue for the year ended December 31, 2022, was $156.2 million, an increase of $8.4 million, or 6%, compared to the prior year, driven by recovery from the COVID-19 pandemic[267]. - Revenue from the OA Pain Management product family increased by 8% for the year ended December 31, 2022, primarily due to higher international sales and growth in adoption of products globally[268]. - Revenue from the Joint Preservation and Restoration product family increased by 4% for the year ended December 31, 2022, driven by improving elective procedure volumes and commercial adoption of new products[268]. - Revenue from the Non-Orthopedic product family decreased by 2% for the year ended December 31, 2022, mainly due to timing of distributor sales and last-time purchases of legacy products[270]. Profitability and Loss - Gross profit for 2023 was $103.1 million, with a gross margin of 62%, up from 60% in 2022, due to higher revenue and improved manufacturing efficiency[243]. - Adjusted gross profit for the year ended December 31, 2023, increased by $7.1 million to $110.1 million, representing 66% of revenue, consistent with the previous year[253]. - Adjusted net loss for 2023 was $4.3 million, a decrease of $2.7 million compared to 2022, attributed to higher revenues and improved operating performance[263]. - The net loss for the year ended December 31, 2023, was $82.7 million, or $5.64 per share, compared to a net loss of $14.9 million, or $1.02 per share, for the prior year, reflecting a $67.8 million increase in net loss[248]. - The company recorded a $62.2 million pre-tax impairment charge on intangible assets in Q4 2023, contributing significantly to the net loss[248]. - Net loss for the year ended December 31, 2022, was $14.9 million, or $1.02 per diluted share, compared to net income of $4.1 million, or $0.28 per diluted share, for the prior year[277]. Expenses - Research and development expenses increased by 16% to $32.7 million, driven by compliance costs and new product development, including the Integrity Implant System[244]. - Selling, general and administrative expenses rose 13% to $95.9 million, influenced by non-recurring costs and increased marketing efforts[245]. - Research and development expenses for the year ended December 31, 2022, were $28.2 million, an increase of 3% compared to the prior year, due to compliance costs and new product development[272]. - Selling, general and administrative expenses for the year ended December 31, 2022, were $84.8 million, an increase of 14% compared to the prior year, primarily related to expansion of commercial capabilities[273]. - The company incurred $15.2 million in stock-based compensation in 2023, reflecting ongoing employee compensation strategies[258]. Tax and Impairment - The effective tax rate for 2023 was 3.1%, down from 20.7% in 2022, primarily due to a valuation allowance on U.S. deferred tax assets[247]. - A non-cash impairment of intangible assets charge of $62.2 million was recorded in Q4 2023 due to lower growth expectations for Parcus Medical and Arthrosurface[246]. - A $62.2 million charge was recorded to intangible assets related to the Arthrosurface and Parcus reporting units due to slower than expected revenue growth[307]. Cash Flow - Cash used in operating activities was $(1.8) million for the year ended December 31, 2023, compared to $4.4 million and $8.4 million for 2022 and 2021, respectively[285]. - Cash used in investing activities was $5.4 million for the year ended December 31, 2023, compared to $7.5 million for 2022[286]. - Cash used in financing activities was $6.3 million for the year ended December 31, 2023, primarily due to $5.0 million for an accelerated stock repurchase program[287]. Product Development and Market Release - The Integrity Implant System is on track for full market release in mid-2024 after completing over 100 cases in limited market release[231]. - The increase in adjusted EBITDA was also supported by a slower ramp-up of commercial spending and overall spending control in 2023[258]. Currency and Inventory - Approximately $12.8 million of revenue was denominated in foreign currencies for the year ended December 31, 2023, primarily in Euro and UK pound sterling[311]. - The company does not engage in foreign currency hedging arrangements, exposing it to potential adverse effects from currency fluctuations[311]. - Inventory write-downs are recorded when inventory is deemed in excess of anticipated demand or obsolete, with evaluations based on historical usage and market conditions[303]. - Goodwill is tested for impairment annually, with no impairment recorded for the legacy Anika reporting unit as of November 30, 2023[306]. Revenue Recognition - Mitek accounted for 45% of total revenues for the year ended December 31, 2023[295]. - Revenue from sales-based royalties is recognized based on estimated net sales reported by commercial partners, with adjustments typically made in the following quarter[295]. - Revenue from distributor sales is recognized upon shipment to the distributor, with no significant concentration of credit risk due to a diversified base of distributors[297]. - No deferred revenue was recorded as of December 31, 2023 and 2022, indicating all revenue was recognized in the period earned[300].

Financial Data and Key Metrics Changes - Total revenue for Q4 2023 grew to $43 million, exceeding expectations, driven by growth in U.S. and international OA pain management [19] - Revenue in OA pain management increased 12% in Q4 to $25.1 million, with international business showing strong growth [20] - Adjusted EBITDA for Q4 was $5.8 million, up from $1.4 million in the same quarter last year, with an adjusted EBITDA margin of 13% [23][24] - For the full year, Anika generated revenue of $166.7 million, a 7% increase compared to the previous year [26] - GAAP gross margin for the full year was 62%, up from 60% in the prior year, while adjusted gross margin remained at 66% [27] Business Line Data and Key Metrics Changes - OA pain management revenues for the full year increased 11% to $101.9 million, driven by strong international growth [26] - Joint preservation and restoration revenue grew 9% to $54.9 million, supported by new product momentum [27] - Non-orthopedic revenues decreased 29% to $9.9 million, primarily due to order timing and last-time buys [27] Market Data and Key Metrics Changes - Cingal experienced over 20% growth internationally, contributing to the overall success in OA pain management [26] - The U.S. market for OA pain management is expected to double from $1 billion to $2 billion with Cingal's expansion [8] Company Strategy and Development Direction - The company is focusing on optimizing performance and driving stronger results, particularly in OA pain management and regenerative solutions [6][15] - A strategic review was undertaken to evaluate options for increasing shareholder value, including potential sales [16] - The company plans to reduce spending and has initiated a workforce reduction of about 9% to drive annualized cost savings of approximately $10 million [17][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of new products and the overall business strategy, aiming for accelerated profitability in 2024 [6][33] - The company anticipates adjusted EBITDA for 2024 to be between $25 million and $30 million, representing a significant increase [31] - Management highlighted the importance of ongoing dialogue with the FDA regarding Cingal and the positive feedback from surgeons on new products [43][64] Other Important Information - The company recorded a non-cash impairment charge of $62.2 million related to intangible assets from previous acquisitions due to lower-than-expected growth in mature products [21][22] - Anika ended Q4 with $72.9 million in cash and no outstanding debt, maintaining a healthy balance sheet [24][25] Q&A Session Summary Question: What areas of the company will be impacted by the workforce reduction? - The main areas impacted are R&D and SG&A, primarily in marketing [38] Question: Are you happy with the results from changes to distributors for the joint preservation business? - Top distributors are performing well, and there is a significant pull for new products like Integrity and X-Twist [41] Question: When do you expect the next meeting with the FDA regarding Cingal? - Ongoing dialogue with the FDA is productive, and clarity on nonclinical data requirements is being sought [43] Question: What contribution did RevoMotion make in the quarter? - Training for about 600 surgeons occurred last year, and focused training will continue for new products [46] Question: Can you provide additional color on the impairment charge related to the Sports Med business? - The impairment charge was due to a reassessment of growth trajectories, with mature products underperforming expectations [52]

Q4 AND YEAR-END 2023 EARNINGS CALL MARCH 13, 2023 ...

EXHIBIT 99.1 Anika Reports Fourth Quarter and Year-End 2023 Financial Results Revenue growth and adjusted EBITDA exceeded expectations in the fourth quarter and full year OA Pain Management achieved record annual revenues of $102 million, up 11% in 2023 Announces cost reduction initiatives providing annualized savings of approximately $10 million Anika positioned to generate adjusted EBITDA of $25 to $30 million in 2024, up over 75% at the midpoint, representing an adjusted EBITDA margin of at least 15% BED ...

BEDFORD, Mass., March 08, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ:ANIK), a global joint preservation company in early intervention orthopedics, today announced that on March 1, 2024, Anika granted non-statutory stock options ("Options") covering an aggregate of 2,500 shares of common stock at a per share exercise price of $25.14, which equaled the closing price of common stock on the Nasdaq Global Select Market ("Closing Price") on the grant date, to one newly hired non-executive employee. ...