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]

Financial Data and Key Metrics Changes - Total revenue for the first quarter was $26.2 million, down 10% compared to the same period in 2024, primarily due to pricing pressure in the OEM channel [9][20] - Gross margin for the first quarter was 56%, down nine percentage points year over year, driven by a $4 million drop in sales of MONOVISC and ORTHOVISC [22][23] - Operating expenses decreased by 12% year over year to $19 million, reflecting cost-saving measures [25] Business Line Data and Key Metrics Changes - Revenue in the commercial channel increased by 18% year over year to $11.3 million, with international OA pain products growing by 13% [20] - The regenerative solutions portfolio achieved 33% growth year over year, driven by the performance of the Integrity product [12][21] - OEM channel revenue decreased by 23% to $14.9 million, primarily due to lower pricing for MONOVISC and ORTHOVISC [20][22] Market Data and Key Metrics Changes - International OA pain management revenue grew by 13% year over year, indicating strong market demand [9][20] - The company is focused on expanding its global reach and strengthening distribution networks to mitigate pricing pressures in the U.S. market [10][11] Company Strategy and Development Direction - The company is advancing its strategic initiatives by focusing on proprietary hyaluronic acid technologies and optimizing its commercial channel [6][7] - Key products like the Integrity Implant System and anticipated U.S. approvals of HYALOFAST and CINGAL are seen as market drivers in tendon and cartilage repair [8][17] - The company is actively working on new product expansion programs to diversify revenue sources beyond J&J [11] Management's Comments on Operating Environment and Future Outlook - Management acknowledged ongoing pricing challenges in the domestic OA pain market and short-term supply production yield issues [5][6] - The company expects a modest pricing rebound in the second quarter, with overall revenue guidance for the OEM channel updated to reflect a 16% to 20% decline [28][29] - Management remains optimistic about the long-term trajectory, driven by investments in regenerative solutions and upcoming product launches [32] Other Important Information - The company ended the quarter with $53 million in cash and no debt, indicating a strong liquidity position [26][70] - Adjusted EBITDA guidance for 2025 has been revised to a range of negative 3% to positive 3%, reflecting lower manufacturing yields and pricing pressures [30][32] Q&A Session Summary Question: Timeline and investment for the CINGAL bioequivalence study - Management expects to begin the study by the end of the year, with further updates to be provided as progress is made [38][39] Question: OEM revenue guidance and expected improvement - The sequential growth in OEM revenue is expected to be driven primarily by pricing, with indications of a pricing rebound in the second quarter [41] Question: Commercial revenue guidance maintenance - The decision to maintain commercial revenue guidance was based on strong Q1 performance, despite tougher comparisons in Q2 [43] Question: Timing for HYALOFAST final module filing - The final module filing for HYALOFAST is expected to be completed by the end of the year, with updates to be provided in future earnings calls [48][49] Question: Distribution plans for CINGAL - Management is exploring distribution opportunities for CINGAL, with more details to come as the regulatory process progresses [67][68] Question: Cash position and sufficiency for regulatory processes - The company has sufficient cash to navigate the regulatory filings for both HYALOFAST and CINGAL, with expectations of improvements in cash flow in the second half of the year [70][71]

Financial Data and Key Metrics Changes - Total revenue for the first quarter was $26.2 million, down 10% compared to the same period in 2024, primarily due to pricing pressure in the OEM channel [9][20] - Gross margin for the first quarter was 56%, down nine percentage points year over year, driven by a $4 million drop in MONOVISC and ORTHOVISC sales [22][23] - Operating expenses decreased by 12% year over year to $19 million, reflecting cost-saving measures [26] Business Line Data and Key Metrics Changes - Revenue in the commercial channel increased by 18% year over year to $11.3 million, with international OA pain products growing by 13% [20] - The regenerative solutions portfolio achieved 33% growth year over year, driven by the performance of the Integrity product [12][20] - OEM channel revenue decreased by 23% to $14.9 million, primarily due to lower pricing for MONOVISC and ORTHOVISC [21] Market Data and Key Metrics Changes - The company experienced ongoing pricing challenges in the domestic OA pain market, impacting overall revenue [6][9] - International OA pain management growth was reported at 13% year over year, indicating strong performance in global markets [9][20] Company Strategy and Development Direction - The company is focusing on leveraging proprietary hyaluronic acid technologies and has made progress in strategic initiatives [7][8] - Plans to diversify revenue sources and grow the OEM channel outside of existing partnerships are underway, particularly through new product expansion programs [11] - The anticipated U.S. approvals of HYALOFAST and CINGAL are seen as key drivers for future growth in tendon and cartilage repair markets [8][18] Management's Comments on Operating Environment and Future Outlook - Management acknowledged ongoing pricing pressures but expressed confidence in the company's ability to return to historic production levels in the second half of the year [35] - The company expects modest pricing rebounds in the second quarter and anticipates accelerated growth in the second half of the year [29][30] - Management remains optimistic about the long-term trajectory, driven by investments in regenerative solutions and upcoming product launches [33] Other Important Information - The company ended the first quarter with $53 million in cash and no debt, indicating a strong liquidity position [27][71] - Adjusted EBITDA guidance for 2025 has been updated to a range of negative 3% to positive 3%, reflecting lower pricing and manufacturing challenges [30][31] Q&A Session Summary Question: Timeline and investment for the CINGAL bioequivalence study - Management expects to begin the study by the end of the year and will provide further updates as progress is made [38][39] Question: OEM guidance and expected improvement in revenue - Sequential growth in OEM revenue is anticipated to be driven primarily by pricing adjustments [41] Question: Commercial revenue guidance maintenance - The decision to maintain guidance was based on strong Q1 performance and expected challenges in Q2 [43] Question: Timing for HYALOFAST final module filing - The final module is expected to be filed by the end of the year, with updates to be provided in future earnings calls [48][49] Question: Distribution plans for CINGAL - Management is exploring distribution opportunities and will provide more details as they develop [68] Question: Cash flow expectations and regulatory process funding - The company has sufficient cash to navigate the regulatory processes for both HYALOFAST and CINGAL [71][72]

Financial Data and Key Metrics Changes - Total revenue for the first quarter was $26.2 million, down 10% compared to the same period in 2024, primarily due to pricing pressure in the OEM channel [8][19] - Gross margin decreased to 56%, down nine percentage points year over year, driven by a $4 million drop in MONOVISC and ORTHOVISC sales [21][22] - Operating expenses were $19 million, down 12% year over year, reflecting cost-saving measures [24] Business Line Data and Key Metrics Changes - Revenue in the commercial channel increased by 18% year over year to $11.3 million, with international OA pain products growing by 13% [19] - Regenerative solutions revenue grew by 33% year over year, driven by the performance of the Integrity product [20][11] - OEM channel revenue decreased by 23% to $14.9 million, primarily due to lower pricing for MONOVISC and ORTHOVISC [20][21] Market Data and Key Metrics Changes - The U.S. market for MONOVISC and ORTHOVISC continues to face pricing volatility, which has not been fully offset by measures implemented by J and J MedTech [9][10] - The company anticipates a modest pricing rebound in the second quarter, but overall OEM revenue is expected to decline by 16% to 20% for the full year [28][29] Company Strategy and Development Direction - The company is focusing on leveraging proprietary hyaluronic acid technologies and expanding its commercial channel, which has shown strong growth [6][11] - Strategic initiatives include diversifying revenue sources and enhancing product offerings, particularly in regenerative solutions [10][12] - The company is advancing its pipeline programs, including HYALOFAST and CINGAL, with expected U.S. launches in 2026 [15][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming short-term manufacturing challenges and returning to historic production levels in the second half of the year [34] - The company remains well-positioned to fund its product pipeline and expects to see improvements in gross margins in the second half of the year [32][70] Other Important Information - The company ended the quarter with $53 million in cash and no debt, indicating strong liquidity to support ongoing operations and regulatory processes [27][69] - Adjusted EBITDA guidance for 2025 has been revised to a range of negative 3% to positive 3%, reflecting lower manufacturing yields and pricing pressures [30][32] Q&A Session Summary Question: Could you elaborate on the timeline and investment needed for the CINGAL bioequivalence study? - Management expects to begin the study by the end of the year and will provide further updates as progress is made [38][39] Question: What drives the expected improvement in OEM revenue through the year? - The improvement is primarily driven by anticipated price stabilization in the second quarter [41] Question: What factors influenced the decision to maintain commercial revenue guidance? - The decision was based on strong Q1 performance and expectations of continued growth despite tougher comparisons in Q2 [42] Question: Can you provide insight into the distribution plans for CINGAL once approved? - The company is exploring various distribution opportunities and will provide more details in the future [65][66] Question: Is there sufficient cash to get through the regulatory process? - Management confirmed that the company has adequate cash to support regulatory filings for both HYALOFAST and CINGAL [69][70]