Anika Therapeutics (ANIK) came out with quarterly earnings of $0.17 per share, missing the Zacks Consensus Estimate of $0.23 per share. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -26.09%. A quarter ago, it was expected that this medical technology company would post a loss of $0.19 per share when it actually produced a loss of $0.31, delivering a surprise of -63.16%.Over the last four quarte ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-14027 Anika Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 04-3145961 (State or Other Jurisdiction of Inc ...

[Anika Reports Second Quarter 2024 Financial Results](index=1&type=section&id=Anika%20Reports%20Second%20Quarter%202024%20Financial%20Results) [Executive Summary & Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Highlights) Anika reported Q2 2024 financial results, highlighting the full market release of the Integrity™ Implant System, revenue in line with expectations with **15% adjusted EBITDA margins**, strong international OA Pain Management revenue growth of **17% in H1 2024**, and an enhanced capital allocation strategy including a new **$40 million share repurchase program** - Full market release of Integrity™ Implant System, a hyaluronic acid (HA)-based scaffold for rotator cuff and other tendon repairs, generating significant market demand[1](index=1&type=chunk) - Delivered revenue in line with expectations with **15% adjusted EBITDA margins**[1](index=1&type=chunk) - Strong first half 2024 international OA Pain Management revenue growth of **17%**[1](index=1&type=chunk) - Enhanced capital allocation strategy with new **$40 million share repurchase program** announced in May 2024[1](index=1&type=chunk) [Second Quarter 2024 Financial Summary](index=1&type=section&id=Second%20Quarter%202024%20Financial%20Summary) Anika's Q2 2024 revenue decreased by **5% to $41.9 million**, primarily due to a **9% decrease in OA Pain Management revenue** and a **26% decrease in Non-Orthopedic revenue**, partially offset by a **7% increase in Joint Preservation and Restoration revenue** Second Quarter 2024 Key Financials (vs. Q2 2023) | Metric | Q2 2024 | Q2 2023 | Change (%) | | :----- | :------ | :------ | :--------- | | Revenue | $41.9M | $44.3M | -5% | | OA Pain Management Revenue | $26.7M | - | -9% | | Joint Preservation and Restoration Revenue | $13.5M | - | +7% | | Non-Orthopedic Revenue | $1.7M | - | -26% | | Gross Margin | 65% | - | - | | Adjusted Gross Margin | 66% | - | - | | Net Loss | ($0.1)M | ($2.741)M | - | | Net Loss Per Share | ($0.01) | ($0.19) | - | | Adjusted Net Income | $2.5M | - | - | | Adjusted Diluted EPS | $0.17 | - | - | | Adjusted EBITDA | $6.3M | $6.272M | +0.29% | | Cash used for operating activities | $1.1M | - | - | | Cash balance | $62.8M | - | - | [CEO Commentary](index=1&type=section&id=CEO%20Commentary) Dr. Cheryl R. Blanchard, President and CEO, expressed satisfaction with Q2 financial performance and progress on the re-focused business strategy towards profitability, highlighting the Integrity Implant System's full market release, strong international OA Pain Management growth, and strategic initiatives for profitability and capital allocation - Full market release of Integrity Implant System in July, with over double the anticipated cases completed during limited market release, demonstrating significant surgeon demand[3](index=3&type=chunk) - OA Pain Management remains a strong, foundational element, with international growth of **17% in H1 2024** for Cingal, Monovisc, and Orthovisc[3](index=3&type=chunk) - Re-focused business strategy in 2024 to accelerate profitability, deploy capital to high-returning programs, and explore strategic alternatives, including a new **$40 million share repurchase program** and cost restructuring[3](index=3&type=chunk) [Strategic Updates](index=1&type=section&id=Strategic%20Updates) [Regenerative Solutions Portfolio Expansion](index=2&type=section&id=Regenerative%20Solutions%20Portfolio%20Expansion) Anika expanded its Regenerative Solutions portfolio with the full market release of the Integrity Implant System in July 2024, an HA-based regenerative scaffold, and is on track to file the first Hyalofast modular PMA submission in 2024 for a US launch by 2026 - Full market release of the Integrity Implant System in July 2024, an HA-based regenerative scaffold, with over **300 successful cases** completed by more than **60 surgeons** during limited market release[3](index=3&type=chunk)[5](index=5&type=chunk) - On track to file the first Hyalofast modular PMA submission in 2024, with final clinical module filing expected in 2025 to support a US product launch by 2026[3](index=3&type=chunk)[5](index=5&type=chunk) [OA Pain Management Leadership](index=2&type=section&id=OA%20Pain%20Management%20Leadership) Anika demonstrated leadership in OA Pain Management with **17% growth in international revenue** during H1 2024, maintaining US market leadership with Monovisc and Orthovisc while progressing towards Cingal's FDA approval to double the US OA Pain market opportunity - International OA Pain Management revenue grew **17% in the first half of 2024** across Cingal, Monovisc, and Orthovisc, driven by market share gains and new country expansion[3](index=3&type=chunk)[6](index=6&type=chunk) - Maintained US market leadership with Monovisc and Orthovisc, while progressing towards Cingal's FDA approval, which is expected to double the US OA Pain market opportunity to **$2 billion**[3](index=3&type=chunk)[6](index=6&type=chunk) [Re-focused Business Strategy and Capital Allocation](index=2&type=section&id=Re-focused%20Business%20Strategy%20and%20Capital%20Allocation) Anika completed cost reduction initiatives, achieving **$10 million annualized expense reduction** and a **73% increase in year-to-date adjusted EBITDA**, and announced a new **$40 million stock repurchase program** - Completed cost reduction initiatives to reduce expenses by **$10 million annualized**, contributing to an **$8.8 million year-to-date adjusted EBITDA**, up **73%** compared to the same period in 2023[3](index=3&type=chunk)[6](index=6&type=chunk) - Announced a new **$40 million stock repurchase program**, with **$15 million** being executed under a 10b5-1 plan by June 2025 and the remainder through open market purchases by June 2026[3](index=3&type=chunk)[6](index=6&type=chunk) [Fiscal 2024 Guidance](index=2&type=section&id=Fiscal%202024%20Guidance) [Fiscal 2024 Guidance Overview](index=2&type=section&id=Fiscal%202024%20Guidance%20Overview) Anika reiterated its fiscal 2024 revenue guidance of **$168 to $173 million**, representing **1% to 4% growth**, with adjusted EBITDA expected towards the lower end of the **$25 to $30 million** range due to product mix Fiscal 2024 Revenue Guidance by Product Family | Product Family | 2024 Guidance Range | YoY Growth | | :------------- | :------------------ | :--------- | | Total Revenue | $168 - $173 million | 1% - 4% | | OA Pain Management | $102 - $104 million | 0% - 2% | | Joint Preservation and Restoration | $58 - $60.5 million | 6% - 10% | | Non-Orthopedic | $8 - $8.5 million | -14% - -19% | - Expects 2024 adjusted EBITDA to be towards the lower end of the **$25 to $30 million range** (approximately **15% adjusted EBITDA margin**), driven by lower US OA Pain Management sales offset by stronger international growth[7](index=7&type=chunk) [Company Information](index=2&type=section&id=Company%20Information) [Conference Call and Webcast Information](index=2&type=section&id=Conference%20Call%20and%20Webcast%20Information) Anika's management hosted a conference call and webcast on August 8, 2024, at 5:00 pm ET to discuss financial results and business highlights, with access details provided for the call and replay - Conference call and webcast held on Thursday, August 8, 2024, at 5:00 pm ET to discuss financial results and business highlights[8](index=8&type=chunk) [About Anika](index=2&type=section&id=About%20Anika) Anika Therapeutics, Inc. is a global joint preservation company focused on early intervention orthopedic care, leveraging expertise in hyaluronic acid and implant solutions for minimally invasive products across various orthopedic segments - Anika Therapeutics, Inc. is a global joint preservation company focused on early intervention orthopedic care, headquartered outside of Boston, Massachusetts[9](index=9&type=chunk) - Core expertise in hyaluronic acid and implant solutions, offering minimally invasive products in Osteoarthritis Pain Management, Regenerative Solutions, Sports Medicine, and Arthrosurface Joint Solutions[9](index=9&type=chunk) [Trademarks](index=3&type=section&id=Trademarks) This section lists key trademarks owned by Anika Therapeutics, Inc. or its subsidiaries, or licensed for its use, including ANIKA, CINGAL, HYALOFAST, INTEGRITY, MONOVISC, and ORTHOVISC - Key trademarks include ANIKA, CINGAL, HYALOFAST, INTEGRITY, MONOVISC, and ORTHOVISC[10](index=10&type=chunk) [Non-GAAP Financial Information](index=3&type=section&id=Non-GAAP%20Financial%20Information) [Non-GAAP Measures Definition](index=3&type=section&id=Non-GAAP%20Measures%20Definition) This section defines Anika's non-GAAP financial measures, including Adjusted Gross Margin, Adjusted EBITDA, and Adjusted Net Income/EPS, clarifying their supplemental nature for internal assessment and investor comparison - Non-GAAP measures are supplemental to GAAP, used for internal performance assessment and executive compensation, and are considered helpful for investors[11](index=11&type=chunk) - Definitions provided for Adjusted Gross Margin (excluding amortization of acquired assets and non-cash product rationalization charges), Adjusted EBITDA (excluding depreciation, amortization, interest, taxes, stock-based compensation, acquisition-related expenses, goodwill impairment, product rationalization, severance, and shareholder activism costs), and Adjusted Net Income/EPS (excluding acquisition-related expenses, goodwill impairment, product rationalization, stock-based compensation, and software project discontinuation, severance, and shareholder activism costs, all tax-effected)[12](index=12&type=chunk)[13](index=13&type=chunk)[14](index=14&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains cautionary statements regarding forward-looking information, emphasizing that actual results may differ materially from expectations due to various risks and uncertainties, with no obligation to update these statements - Press release contains forward-looking statements subject to significant risks, uncertainties, and other factors[16](index=16&type=chunk) - Actual results could differ materially due to factors such as successful completion of clinical trials, timely regulatory approvals, commercialization ability, manufacturing efficiency, economic conditions, and ability to achieve growth targets[16](index=16&type=chunk)[17](index=17&type=chunk) [Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Consolidated%20Financial%20Statements%20(Unaudited)) [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) The consolidated statements of operations show Anika's financial performance for Q2 2024 with **$41.9 million revenue** and a net loss of **($0.088) million**, and for H1 2024 with **$82.4 million revenue** and a net loss of **($4.6) million** Consolidated Statements of Operations (in thousands) | Metric | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :-------------------------------- | :------ | :------ | :------ | :------ | | Revenue | $41,921 | $44,302 | $82,444 | $82,226 | | Cost of Revenue | $14,556 | $15,330 | $30,451 | $30,411 | | Gross Profit | $27,365 | $28,972 | $51,993 | $51,815 | | R&D Expenses | $7,398 | $8,914 | $15,562 | $17,314 | | SG&A Expenses | $19,806 | $23,689 | $41,333 | $50,685 | | Total Operating Expenses | $27,204 | $32,603 | $56,895 | $67,999 | | Income (loss) from operations | $161 | ($3,631) | ($4,902) | ($16,184) | | Interest and other income (expense), net | $595 | $561 | $1,187 | $1,100 | | Income (loss) before income taxes | $756 | ($3,070) | ($3,715) | ($15,084) | | Provision for (benefit from) income taxes | $844 | ($329) | $887 | ($1,993) | | Net loss | ($88) | ($2,741) | ($4,602) | ($13,091) | [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets present Anika's financial position as of June 30, 2024, with total assets decreasing to **$262.7 million** from **$270.6 million** at year-end 2023, and cash decreasing to **$62.8 million** Consolidated Balance Sheets (in thousands) | Asset/Liability/Equity | June 30, 2024 | December 31, 2023 | | :-------------------------------- | :------------ | :---------------- | | **ASSETS** | | | | Cash and cash equivalents | $62,822 | $72,867 | | Accounts receivable, net | $33,773 | $35,961 | | Inventories, net | $51,464 | $46,386 | | Total current assets | $155,000 | $163,309 | | Total assets | $262,655 | $270,632 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Accounts payable | $9,994 | $9,860 | | Accrued expenses and other current liabilities | $16,127 | $21,199 | | Total current liabilities | $26,121 | $31,059 | | Total stockholders' equity | $210,338 | $212,265 | | Total liabilities and stockholders' equity | $262,655 | $270,632 | [Reconciliation of Non-GAAP Financial Measures (Unaudited)](index=5&type=section&id=Reconciliation%20of%20Non-GAAP%20Financial%20Measures%20(Unaudited)) [Reconciliation of GAAP Gross Profit to Adjusted Gross Profit](index=5&type=section&id=Reconciliation%20of%20GAAP%20Gross%20Profit%20to%20Adjusted%20Gross%20Profit) This section reconciles GAAP Gross Profit to Adjusted Gross Profit, showing Q2 2024 Adjusted Gross Profit at **$27.5 million** (**66% margin**) compared to GAAP Gross Profit of **$27.4 million** (**65% margin**), primarily due to acquisition-related intangible asset amortization Reconciliation of GAAP Gross Profit to Adjusted Gross Profit (in thousands) | Metric | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :-------------------------------- | :------ | :------ | :------ | :------ | | Gross Profit | $27,365 | $28,972 | $51,993 | $51,815 | | Product rationalization related charges | - | - | $472 | - | | Acquisition related intangible asset amortization | $154 | $1,561 | $311 | $3,123 | | Adjusted Gross Profit | $27,519 | $30,533 | $52,776 | $54,938 | | Unadjusted Gross Margin | 65% | 65% | 63% | 63% | | Adjusted Gross Margin | 66% | 69% | 64% | 67% | [Reconciliation of GAAP Net Income to Adjusted EBITDA](index=6&type=section&id=Reconciliation%20of%20GAAP%20Net%20Income%20to%20Adjusted%20EBITDA) This section reconciles GAAP Net Loss to Adjusted EBITDA, with Q2 2024 Adjusted EBITDA at **$6.3 million**, and H1 2024 Adjusted EBITDA significantly increasing to **$8.8 million** from **$5.1 million** in the prior year Reconciliation of GAAP Net Income to Adjusted EBITDA (in thousands) | Metric | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :-------------------------------- | :------ | :------ | :------ | :------ | | Net loss | ($88) | ($2,741) | ($4,602) | ($13,091) | | Interest and other (income) expense, net | ($595) | ($561) | ($1,187) | ($1,100) | | Provision for (benefit from) income taxes | $844 | ($329) | $887 | ($1,993) | | Depreciation and amortization | $1,889 | $1,764 | $3,755 | $3,528 | | Stock-based compensation | $3,891 | $4,150 | $7,481 | $7,867 | | Product rationalization | - | - | $472 | - | | Arbitration settlement | - | - | - | $3,250 | | Acquisition related intangible asset amortization | $169 | $1,787 | $366 | $3,574 | | Discontinuation of software development project | ($1,404) | - | ($1,404) | - | | Severance costs | - | - | $839 | - | | Costs of shareholder activism | $1,584 | $2,202 | $2,185 | $3,033 | | Adjusted EBITDA | $6,290 | $6,272 | $8,792 | $5,068 | [Reconciliation of GAAP Net Income to Adjusted Net Income and Adjusted Diluted EPS](index=6&type=section&id=Reconciliation%20of%20GAAP%20Net%20Income%20to%20Adjusted%20Net%20Income%20and%20Adjusted%20Diluted%20EPS) This section reconciles GAAP Net Loss and Diluted EPS to their adjusted counterparts, showing Q2 2024 Adjusted Net Income of **$2.5 million** and Adjusted Diluted EPS of **$0.17**, significantly higher than GAAP figures Reconciliation of GAAP Net Income to Adjusted Net Income (in thousands) | Metric | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :------------------------------------------------ | :------ | :------ | :------ | :------ | | Net loss | ($88) | ($2,741) | ($4,602) | ($13,091) | | Product rationalization, tax effected | - | - | $514 | - | | Arbitration settlement, tax effected | - | - | - | $2,800 | | Share-based compensation, tax effected | $2,393 | $3,712 | $8,154 | $6,779 | | Acquisition related intangible asset amortization, tax effected | $103 | $1,598 | $398 | $3,080 | | Discontinuation of software development project, tax effected | ($864) | - | ($1,530) | - | | Severance costs, tax effected | - | - | $914 | - | | Costs of shareholder activism, tax effected | $975 | $1,970 | $2,381 | $2,613 | | Adjusted net income | $2,519 | $4,539 | $6,229 | $2,181 | Reconciliation of GAAP Diluted EPS to Adjusted Diluted EPS | Metric | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :------------------------------------------------ | :------ | :------ | :------ | :------ | | Diluted net loss per share | ($0.01) | ($0.19) | ($0.31) | ($0.89) | | Product rationalization, tax effected | - | - | $0.03 | - | | Arbitration settlement, tax effected | - | - | - | $0.19 | | Share-based compensation, tax effected | $0.16 | $0.25 | $0.55 | $0.46 | | Acquisition related intangible asset amortization, tax effected | $0.01 | $0.11 | $0.03 | $0.21 | | Discontinuation of software development project, tax effected | ($0.06) | - | ($0.10) | - | | Severance costs, tax effected | - | - | $0.06 | - | | Costs of shareholder activism, tax effected | $0.07 | $0.14 | $0.16 | $0.18 | | Adjusted diluted net income per share | $0.17 | $0.31 | $0.42 | $0.15 | [Revenue by Product Family (Unaudited)](index=7&type=section&id=Revenue%20by%20Product%20Family%20(Unaudited)) [Revenue by Product Family Breakdown](index=7&type=section&id=Revenue%20by%20Product%20Family%20Breakdown) This section details Anika's revenue breakdown by product family, showing Q2 2024 total revenue decreased by **5% to $41.9 million**, primarily due to a **9% decline in OA Pain Management revenue**, while Joint Preservation and Restoration revenue increased by **7%** Revenue by Product Family (in thousands) | Product Family | Q2 2024 | Q2 2023 | $ Change (QoQ) | % Change (QoQ) | H1 2024 | H1 2023 | $ Change (YoY) | % Change (YoY) | | :-------------------------------- | :------ | :------ | :------------- | :------------- | :------ | :------ | :------------- | :------------- | | OA Pain Management | $26,658 | $29,334 | $(2,676) | -9% | $50,976 | $51,967 | $(991) | -2% | | Joint Preservation and Restoration | $13,554 | $12,660 | $894 | 7% | $27,395 | $26,113 | $1,282 | 5% | | Non-Orthopedic | $1,709 | $2,308 | $(599) | -26% | $4,073 | $4,146 | $(73) | -2% | | Total Revenue | $41,921 | $44,302 | $(2,381) | -5% | $82,444 | $82,226 | $218 | 0% |

BEDFORD, Mass., July 25, 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 second quarter 2024 financial results after the close of the market on Thursday, August 8, 2024 and hold its investor conference call on the same day, at 5:00 p.m. ET to discuss its financial results and business highlights. The conference call can be accessed by dialing 1-800-717-1738 (toll-free d ...

BEDFORD, Mass., July 25, 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 second quarter 2024 financial results after the close of the market on Thursday, August 8, 2024 and hold its investor conference call on the same day, at 5:00 p.m. ET to discuss its financial results and business highlights. The conference call can be accessed by dialing 1-800-717-1738 (toll-free ...

Integrity and its complete arthroscopic instrumentation platform are now fully available in the U.S., expanding Anika's proprietary hyaluronic acid (HA) regenerative portfolio Over 300 surgeries completed during the limited market release, highlighting the growing interest and commercial demand across a wide range of tendon repairs BEDFORD, Mass., July 11, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ:ANIK), a global joint preservation company focused on early intervention orthopedics, today ann ...

Integrity and its complete arthroscopic instrumentation platform are now fully available in the U.S., expanding Anika’s proprietary hyaluronic acid (HA) regenerative portfolio Over 300 surgeries completed during the limited market release, highlighting the growing interest and commercial demand across a wide range of tendon repairs BEDFORD, Mass., July 11, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company focused on early intervention orthopedics, today an ...

Core Insights - Anika Therapeutics has appointed Joseph Capper and William Jellison to its Board of Directors as part of a cooperation agreement with Caligan Partners LP [1][4] - The company has authorized a new $40 million share repurchase program, with $15 million to be executed through a 10b5-1 plan by June 30, 2025, and the remainder in the open market by June 30, 2026 [2] Board Appointments - Joseph Capper, CEO of MIMEDX, and William Jellison, former CFO of Stryker, bring nearly 50 years of combined experience in MedTech to the Board [1][3] - Both new directors will serve on the Capital Allocation Committee, contributing to the company's strategy of sustainable profitability [3][4] Financial Performance - Anika expects to generate $25-$30 million in adjusted EBITDA for 2024, representing an increase of over 75% at the midpoint compared to 2023 [3] - The company has implemented cost reduction initiatives to enhance operational and financial performance [3] Share Repurchase Program - The new $40 million share repurchase program replaces the previous program announced in April 2023 [2] - The buyback will be subject to stock prices, economic conditions, and other considerations [2] Cooperation Agreement - Under the cooperation agreement, Caligan has agreed to support the Board's full slate of directors at the 2024 Annual Meeting [4] - The agreement includes customary standstill and voting commitments [4] Company Overview - Anika Therapeutics focuses on joint preservation and early intervention orthopedic care, leveraging expertise in hyaluronic acid and implant solutions [7] - The company aims to provide minimally invasive products for various orthopedic applications, including osteoarthritis pain management and sports medicine [7]

Financial Data and Key Metrics Changes - Overall revenue for Q1 2024 increased by 7% year-over-year to $40.5 million, driven by strong demand and favorable order timing [8][19] - OA Pain Management revenue rose 7% to $24.3 million, attributed to growing market demand and favorable ordering patterns [9][19] - Joint preservation and restoration revenue increased by 3% to $13.8 million, supported by recent product launches [10][20] - Non-orthopedic revenue surged by 29% to $2.4 million, reflecting growing demand in high-risk veterinary sales [20] - Gross margin improved to 61% from 60%, while adjusted gross margin decreased to 62% from 64% due to production inefficiencies [20][21] - Net loss narrowed to $4.5 million or $0.31 per share, compared to a net loss of $10.4 million or $0.71 per share in the previous year [22] - Adjusted EBITDA increased to $2.5 million from a negative $1.2 million, with an adjusted EBITDA margin of 6% [22] Business Line Data and Key Metrics Changes - OA Pain Management remains the largest product family, with a revenue increase of 7% [19] - Joint preservation and restoration revenue growth was driven by new product launches, despite headwinds from mature products [10][20] - The Integrity Implant System has seen over 200 cases completed, indicating strong adoption and positive clinical feedback [11] - The X-Twist Fixation System has achieved over 10,000 global implantations, marking significant market penetration [13] Market Data and Key Metrics Changes - Cingal is positioned as a key driver in over 40 countries outside the U.S., with ongoing exploration of partnership opportunities in select Asian markets [9] - Hyalofast is performing well internationally, now sold in over 35 countries, with plans for a U.S. launch by 2026 [12] Company Strategy and Development Direction - The company is focused on optimizing performance and driving profitability through cost reduction initiatives, aiming for $10 million in annualized savings [8][25] - Continued investment in the HA-based regenerative solutions pipeline is a priority, with plans to file for Hyalofast's PMA this year [26] - The company is committed to maximizing shareholder value while investing in growth opportunities [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2024 guidance, with expectations for revenue growth in the second half of the year [8][24] - The company anticipates a stronger performance in joint preservation and restoration due to the full market release of Integrity [24] - Management remains optimistic about the competitive landscape, particularly regarding the upcoming launch of Hyalofast [39] Other Important Information - The CFO, Mike Levitz, announced his departure effective June 3rd, with Steve Griffin set to take over [15][16] - The company is on track to deliver positive adjusted net income and generate positive free cash flow in 2024 [26] Q&A Session Summary Question: Guidance on OA Pain Management business performance - Management indicated that the OA Pain Management business is growing above market, but noted challenges due to volatile order timing [31][32] Question: Competitive dynamics in the HA injection market - Management acknowledged the competitive landscape but expressed confidence in Hyalofast's market entry and differentiation [39] Question: Growth rates for the joint business and mature products - Management confirmed that while mature products face headwinds, new products are driving growth and will continue to be marketed [41][43] Question: FDA feedback on Cingal and non-clinical data requirements - Management is awaiting clarity on non-clinical testing requirements from the FDA and remains optimistic about the process [45][58] Question: Gross margin expectations for the year - Management expects gross margin to improve in the second half of the year due to favorable product mix and resolution of production inefficiencies [50][62]

Q1 2024 EARNINGS CALL MAY 8, 2024 Anika. Restore Active Living. SAF ...