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- **Commercial Channel Dominance**: 22% YoY growth in Commercial Channel offsets OEM decline, driven by Integrity's 25% YoY procedure growth and international expansion.
- **Product Pipeline Progress**: Hyalofast PMA submission completed; Cingal bioequivalence study initiation on track for late 2025. Over 1 million Cingal injections globally.
- **Financial Discipline**: 12% YoY SG&A reduction and $6.9M operating cash flow highlight cost control. $15M share buyback announced.
- **Growth Catalysts**: New Integrity SKUs launching in Q4; Hyalofast FDA engagement expected; Cingal U.S. launch timeline hinges on bioequivalence study completion.

**【Management Opening Remarks】**
- Anika reported Q3 2025 revenue of $27.8 million, down 6% YoY, driven by J&J's pricing pressure in the OEM channel. Commercial Channel revenue grew 22% YoY to $12 million, offsetting OEM declines.
- The company reaffirmed its focus on cost control, with SG&A expenses down 12% YoY and operating expenses down 3%.
- A second $15 million share repurchase program was announced, reflecting capital return priorities.

**【CEO Commentary】**
- **Commercial Channel Momentum**: Integrity Implant system delivered 25% YoY growth, with 500 procedures performed in Q3 and 300 surgeon users. New SKUs for hip, knee, and ankle applications are being rolled out.
- **Regulatory Progress**: Hyalofast PMA submission completed, with Phase III FastTRACK study showing clinically meaningful improvements in pain and function. Cingal bioequivalence study initiation on track for late 2025.
- **International Expansion**: Hyalofast and Cingal achieved 21% YoY growth in international OA Pain Management, with Cingal surpassing 1 million injections globally.

**【CFO Financial Commentary】**
- **Revenue Breakdown**: Commercial Channel ($12M, +22% YoY) offset OEM Channel decline (-20% YoY) due to J&J pricing pressure. Monovisc unit volume up 11% YoY, but average price down 17%.
- **Gross Margin**: 56% in Q3, down 10ppt YoY due to lower J&J sales, but up 5ppt sequentially from production recovery.
- **Operating Expenses**: Total OpEx $18.8M (-3% YoY), with R&D up 17% due to Cingal pre-filing costs. Adjusted EBITDA $0.9M, breakeven vs. prior guidance.
- **Cash Flow**: Operating cash flow $6.9M (+38% YoY), with $58M cash on hand and no debt.

**【Q&A Highlights】**
- **Integrity Growth Strategy**: Equal focus on new surgeon training and existing surgeon adoption, with 60% of users performing multiple cases. Q4 SKUs expansion expected to accelerate adoption.
- **Cingal Timeline**: Bioequivalence study start by end-2025, with NDA filing dependent on study completion. Toxicity study completion in Q1 2026.
- **Capital Allocation**: Prioritize internal investments (e.g., Integrity, Hyalofast) > CapEx > share buybacks. No M&A plans.
- **Production Issues**: Q3 disruptions resolved, with capacity restored by year-end. Gross margin expected to stabilize near 55-60% range, excluding J&J pricing volatility.

Anika Therapeutics, Inc. (ANIK) Q3 2025 Earnings Call Transcript

- **Integrity Outperforms**: Regenerative solutions revenue up 41% YoY, Integrity on track to double in 2025 with new SKUs targeting $40M market.
- **Hyalofast Delayed**: FDA submission planned for Q4 2025, but commercial launch pushed to 2027 due to clinical trial challenges.
- **Gross Margin Recovery**: H2 2025 margin expected at 58-59%, driven by resolved manufacturing issues, but J&J pricing pressures persist.
- **Cost Control**: 17% YoY reduction in operating expenses, maintaining strong liquidity with $53M cash.

**【CEO Summary Section】**
- **Hyalofast Clinical Trial Update**: Missed primary endpoints due to microfracture arm challenges and COVID-related data loss, but showed consistent improvement over comparator. Submission of full data package to FDA planned for Q4 2025, with commercial launch delayed to 2027.
- **Integrity Growth**: Regenerative solutions revenue up 41% YoY, Integrity on track to more than double in 2025. New SKUs for foot/ankle procedures launched in limited release, targeting $40M addressable market.
- **Financial Overview**: Q2 revenue $28.2M (-8% YoY), regenerative solutions +41% YoY. Operating expenses down 17% YoY, adjusted EBITDA flat at -$200K.

**【CFO Financial Commentary】**
- **Gross Margin Dynamics**: Q2 gross margin 51% (-16ppt YoY) due to $3M one-time manufacturing charge. Excluding charge, margin >60%. Guidance for 58-59% in H2 2025, with full year margin impacted by J&J pricing and Cingal costs.
- **Channel Performance**: Commercial channel ($11.9M flat YoY) driven by Integrity growth, offset by 10% decline in international OA Pain. OEM channel ($16.3M -13% YoY) reflects J&J pricing pressure.
- **Cash Position**: $53M cash on hand, $1.4M Q2 capex for MA facility expansion. No debt, no capital raise needed.

**【Q&A Highlights】**
- **Gross Margin Outlook**: H2 2025 improvement driven by resolved production issues, but long-term margin pressure from J&J channel.
- **Integrity Expansion**: Surgeons using existing Integrity SKUs in new anatomies; new SKUs expected to boost 2026+ sales.
- **FDA Strategy**: FDA encouraged submission of Hyalofast full data package, including secondary endpoints and international studies, under Breakthrough Devices program.
- **Cash Management**: Operating cash flow improving, capex focused on supporting growth in Integrity, Cingal, and Hyalofast.


Anika Therapeutics, Inc. (ANIK) Q2 2025 Earnings Call Transcript

- **Commercial Channel Strength**: 18% YoY growth driven by 33% regenerative solutions expansion and 13% international OA pain gains.
- **Integrity Momentum**: 300+ surgeries in Q1, targeting >2x 2024 procedures with new foot/ankle geometries.
- **Hyalofast & Cingal Progress**: Hyalofast PMA module 2 filed on time; Cingal bioequivalence study path confirmed, with NDA filing pending completion.
- **Financial Challenges**: OEM channel down 23% Q1 due to U.S. pricing, with 2025 EBITDA guidance adjusted to -3% to +3%.
- **Cash Management**: $53M on hand; sufficient liquidity for 2025 initiatives.

**【CEO Opening Remarks】**
- Q1 2025 revenue: $26.2M (-10% YoY), driven by 23% decline in OEM channel due to U.S. pricing pressure. Commercial channel grew 18% YoY, with international OA pain up 13% and regenerative solutions up 33%.
- Key achievements: 
  - Integrity sales grew 33% YoY, with 300+ surgeries in Q1 and >1% market share of U.S. soft tissue augmentation.
  - Hyalofast PMA module 2 filed on time; Cingal bioequivalence study path confirmed with FDA.
  - Operating expenses down 12% YoY, with $4M+ cost savings.

**【CFO Financial Review】**
- Gross margin: 56% (-9ppt YoY) due to lower J&J sales and production inefficiencies. Q2 gross margin expected to stabilize, with H2 targeting 58-59%.
- OpEx: $19M (-12% YoY), with SG&A down 14% and R&D down 5%.
- Cash: $53M at end of Q1; $4M share buyback completed, with no further updates on remaining $11M.
- 2025 guidance: 
  - Commercial channel: $47-49.5M (12-18% growth)
  - OEM channel: $62-65M (-16-20% YoY)
  - Adjusted EBITDA: -3% to +3% (vs. prior 8-10% range) due to pricing, manufacturing, and Cingal study costs.

**【Q&A Highlights】**
1. **Cingal Bioequivalence Study**: 
   - Study to begin by end-2025; NDA filing contingent on successful completion.
   - 2025 costs: ~0.5ppt EBITDA impact.
2. **OEM Channel Outlook**: 
   - Sequential Q2 improvement expected due to pricing rebound, but full-year decline of 18% anticipated.
3. **Integrity Growth**: 
   - 300+ surgeries in Q1, targeting >2x 2024 procedures. New foot/ankle geometries launching in 2025.
4. **Hyalofast Regulatory Path**: 
   - Module 3 filing expected by end-2025; U.S. launch in 2026.
5. **Cash Position**: 
   - Sufficient funds for regulatory efforts; no immediate need for additional capital.

Anika Therapeutics (ANIK)-9 May 25-2025 Q1 Earnings call transcript

- **Revenue Resilience**: Q4 2024 revenue growth (+1% YoY) driven by commercial channel expansion
- **Integrity Breakthrough**: 3rd consecutive quarter of >40% sequential growth, clinical data showing no retears at 6 months
- **Strategic Restructuring**: Parcus Medical divestiture finalized, focusing resources on high-margin HA products
- **Pipeline Momentum**: Hyalofast U.S. launch in 2026, Cingal bioequivalence study progressing with FDA


**【CEO Business Highlights】**
- **Q4 2024 Revenue**: $30.6 million (+1% YoY), Full Year 2024: $119.9 million (-1% YoY)
- **Commercial Channel Growth**: +25% Q4, +17% Full Year
- **International OA Pain Management**: +22% Q4, +16% Full Year
- **Integrity Implant System**: 
  - Q4 2024 Surgeries: >300 (1,000+ globally since launch)
  - Sequential Growth: >40% for 3rd consecutive quarter
  - Clinical Data: 3-month pain reduction and 6-month strength improvement with no retears
- **Pipeline Progress**: 
  - Hyalofast PMA Module 2 filed in Q1 2025, targeting U.S. launch in 2026
  - Cingal bioequivalence study design finalized with FDA

**【CFO Financial Updates】**
- **Parcus Medical Sale**: Completed to Medacta in Q1 2025
- **Financial Impact**: 
  - Cash received at closing (subject to post-closing adjustments)
  - Transition services agreement for 2025
- **Cost Optimization**: Shifting focus to high-margin HA technologies


Anika Therapeutics (ANIK)-12 Mar 25-2024 Q4 Earnings call transcript

Anika Therapeutics (ANIK)-31 Oct 24-2024 Q3 Earnings call transcript

Anika Therapeutics (ANIK)-8 Aug 24-2024 Q2 Earnings call transcript

Anika Therapeutics (ANIK)-8 May 24-2024 Q1 Earnings call transcript

Anika Therapeutics (ANIK)-13 Mar 24-2023 Q4 Earnings call transcript

Anika Therapeutics (ANIK)-2 Nov 23-2023 Q3 Earnings call transcript

Anika Therapeutics (ANIK)-9 May 23-2023 Q1 Earnings call transcript

Anika Therapeutics (ANIK)-6 Mar 23-2022 Q4 Earnings call transcript

Anika Therapeutics (ANIK)-9 Nov 22-2022 Q3 Earnings call transcript

Anika Therapeutics (ANIK)-6 Aug 22-2022 Q2 Earnings call transcript

Anika Therapeutics (ANIK)-7 May 22-2022 Q1 Earnings call transcript

Anika Therapeutics (ANIK)-9 Mar 22-2021 Q4 Earnings call transcript

Anika Therapeutics (ANIK)-5 Nov 21-2021 Q3 Earnings call transcript

Anika Therapeutics (ANIK)-7 Aug 21-2021 Q2 Earnings call transcript

Anika Therapeutics (ANIK)-9 May 21-2021 Q1 Earnings call transcript

Anika Therapeutics (ANIK)-5 Mar 21-2020 Q4 Earnings call transcript

Anika Therapeutics (ANIK)-4 Nov 20-2020 Q3 Earnings call transcript

Anika Therapeutics (ANIK)-2 Aug 20-2020 Q2 Earnings call transcript

Anika Therapeutics (ANIK)-9 May 20-2020 Q1 Earnings call transcript

Anika Therapeutics (ANIK)-20 Feb 20-2019 Q4 Earnings call transcript

Anika Therapeutics (ANIK)-24 Oct 19-2019 Q3 Earnings call transcript

Anika Therapeutics (ANIK)-24 Jul 19-2019 Q2 Earnings call transcript

Anika Therapeutics (ANIK)-3 May 19-2019 Q1 Earnings call transcript

Anika Therapeutics (ANIK)-22 Feb 19-2018 Q4 Earnings call transcript

Anika Therapeutics (ANIK)-24 Oct 18-2018 Q3 Earnings call transcript

Anika Therapeutics (ANIK)-26 Jul 18-2018 Q2 Earnings call transcript

Anika Therapeutics (ANIK)-3 May 18-2018 Q1 Earnings call transcript

Anika Therapeutics (ANIK)-22 Feb 18-2017 Q4 Earnings call transcript

Anika Therapeutics (ANIK)-26 Oct 17-2017 Q3 Earnings call transcript

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