ANGO Q4 2025: Strong Thrombectomy Momentum, 53.5–55.5% Margin Outlook
- Ancillary Blood Return Product Opportunity: Management is actively working on a blood return version of AlphaVac to address market expectations, which can further differentiate their thrombectomy portfolio and unlock additional growth potential.
- NanoKnife Growth from Reimbursement: The company anticipates that reimbursement approval effective January 2026 will accelerate NanoKnife adoption, especially as increased urologist awareness and clinical data support its long‐term growth.
- Robust Mechanical Thrombectomy Performance: The Q&A highlighted strong market acceptance of the mechanical thrombectomy suite, with both AngioVac and AlphaVac showing sequential revenue growth, reinforcing a compelling growth story for the medtech segment.
- Regulatory Approval Uncertainty: The company is still in discussions with the FDA over the pathway for its new blood return version of AlphaVac, which may require a 510(k) process and potentially additional clinical trials. This uncertainty could delay product launch and impact overall growth.
- Tariff Impact Concerns: The unpredictable and evolving tariff environment poses a risk to cost structures and margins. With recent tariff expenses already affecting gross margins, further tariffs could pressure profitability.
- Uncertain NanoKnife Adoption: Despite expectations for growth driven by reimbursement changes, the NanoKnife business faces challenges due to a complex, patchwork reimbursement landscape and modest capital sales, potentially delaying or limiting accelerated adoption.
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Revenue | FY 2025 | $285 million to $288 million | no current guidance | no current guidance |
Med Tech Net Sales Growth | FY 2025 | 14% to 16% | no current guidance | no current guidance |
Med Device Net Sales | FY 2025 | Expected to remain flat | no current guidance | no current guidance |
Gross Margin | FY 2025 | 53% to 54% | no current guidance | no current guidance |
Adjusted EBITDA | FY 2025 | $4 million to $5 million | no current guidance | no current guidance |
Adjusted Loss Per Share | FY 2025 | $0.31 to $0.34 | no current guidance | no current guidance |
Net Sales | FY 2026 | no prior guidance | $305,000,000 to $310,000,000 | no prior guidance |
MedTech Net Sales Growth | FY 2026 | no prior guidance | 12% to 15% | no prior guidance |
Med Device Sales | FY 2026 | no prior guidance | Expected to be roughly flat | no prior guidance |
Gross Margin | FY 2026 | no prior guidance | 53.5% to 55.5% | no prior guidance |
Adjusted EBITDA | FY 2026 | no prior guidance | $3,000,000 to $8,000,000 | no prior guidance |
Adjusted Loss Per Share | FY 2026 | no prior guidance | negative $0.35 to negative $0.25 | no prior guidance |
Cash Flow | FY 2026 | no prior guidance | Expected to be cash flow positive for the full year, with approximately $20,000,000 used in Q1 | no prior guidance |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
Mechanical Thrombectomy Performance | Q1–Q3 discussions highlighted overall strong performance with robust revenue growth, notable clinical data, and synergies between AngioVac and AlphaVac – although Q1 noted a slight decline due to tough year‐over‐year comparisons. | Q4 call emphasized continued strong performance with a 44.7% YoY revenue increase, solid clinical trial results (APeX, RECOVER AV) and plans for additional sales force expansion to support sequential growth. | Consistent growth driver with evolving emphasis on enhanced clinical evidence and expanding sales support. |
Regulatory and Reimbursement Uncertainties | Previous periods (Q1–Q3) focused on obtaining expanded FDA indications, pursuing new CPT codes, and leveraging clinical data to support reimbursement for NanoKnife, AlphaVac, and Auryon. Q1 discussed FDA submissions and parallel pathing for NanoKnife; Q2 and Q3 stressed working on coverage and coding initiatives. | Q4 call continued addressing these uncertainties by noting NanoKnife’s expanded indications (e.g., for pancreatic cancer) and a new CPT Category I code effective January 2026, while also outlining ongoing FDA discussions for the blood return version of AlphaVac. | A consistent focus on regulatory approvals and reimbursement pathways persists, with Q4 showing additional attention to reimbursement nuances and new product features. |
NanoKnife Adoption and Reimbursement Dynamics | Q1 discussions revealed mixed revenue performance due to distributor order timing and highlighted FDA submission data from the PRESERVE study; Q2 noted encouraging adoption and 23% probe revenue growth; and Q3 underscored robust adoption in prostate cancer with anticipation of the upcoming CPT code. | In Q4, NanoKnife adoption remains strong with prostate-related procedures accounting for 81% of treatments, while mixed revenue trends (decline in capital sales but growth in disposables) and complex reimbursement dynamics continue to underpin the narrative. | Adoption is consistently positive, though revenue shows volatility. The reimbursement complexity remains, with gradual growth expected as new codes take effect. |
Ancillary Blood Return Product Opportunity | Not mentioned in Q1, Q2, or Q3 calls. | Q4 introduced discussion of an ancillary blood return iteration of AlphaVac. The new version—designed to address market expectations for blood return— is undergoing the 510(k) process, signaling a potential expansion of AlphaVac’s capabilities. | New topic emerging in Q4; represents an opportunity to enhance product differentiation and address unmet market needs. |
Auryon Expansion and Dependence on Clinical Trial Outcomes | Earlier periods discussed geographic expansion: Q1 detailed initial U.S. and European launches with new product variations (e.g., Auryon XL) and emphasized evolving clinical data; Q2 and Q3 further highlighted the importance of clinical trials (e.g., AMBITION BTK, global training efforts) for supporting expansion. | Q4 stressed significant expansion in hospitals (with a 36% revenue share) and strong international traction (over $1M revenue in Europe). It also reiterated reliance on ongoing clinical trials (Ambition BTK) to support further market expansion. | Auryon continues to expand both domestically and internationally with a heavy reliance on robust clinical trial outcomes to validate and drive further growth. |
Manufacturing Transition Impacts on Margins | Q1 called out double-paying overhead during the transition, with expected long-term savings of $15M annually by FY2027; Q2 noted under-absorption due to the ongoing shift (from Queensbury to Costa Rica); and Q3 referenced execution in transitioning production to lower-cost regions while monitoring tariff risks. | In Q4, the company highlighted progress in the manufacturing transfer, expecting full benefit to be realized by the end of calendar 2025 with $15M annualized savings by FY2027, and noted early benefits starting to materialize. | Consistent discussion of short-term margin pressures due to transitional costs with an optimistic outlook for significant long-term savings once the program completes. |
Tariff Impact Concerns Affecting Cost Structures | No mention in Q1 and Q2. In Q3, the focus was on monitoring tariffs with reassurance due to domestic manufacturing and supplier base. | Q4 introduced explicit concerns with tariffs, reporting $1.6M in expenses in Q4 and projecting an annual impact of $4–6M in FY2026, though the company remains confident in its strategic execution. | A newly emerged topic in Q4; tariffs are now being identified as a tangible cost risk with potential ongoing impact, despite overall confidence in the company’s trajectory. |
Sales Force Expansion Execution Challenges | Q1 did not mention challenges; Q2 emphasized positive sales force developments with effective training and new hires; and Q3 highlighted planned expansion and successful sales team synergies for both the thrombectomy portfolio and Auryon. | Q4 did not highlight any new challenges or updates regarding sales force execution, indicating that previous positive developments continue without significant issues [N/A]. | Earlier periods focused on positive expansion with no major challenges; by Q4 the topic is not consistently mentioned, suggesting stable execution and lower emphasis on issues. |
International Market Dynamics and Order Volatility | Q1 provided details on distributor order volatility overseas causing revenue choppiness, while Q2 and Q3 touched on efforts in Europe (e.g., Auryon launch, complexity of European reimbursement) with less emphasis on volatility. | Q4 briefly mentioned strong international traction for Auryon in Europe (over $1M in revenue) without reference to order volatility, showing stabilization in international markets. | Volatility in international orders appears to have moderated over time, with earlier concerns smoothing out as the market stabilizes and gains traction, especially for Auryon. |
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FY2026 Product Mix
Q: What drives FY2026 medtech sales growth?
A: Management expects strong medtech growth driven by mechanical thrombectomy and steadily growing NanoKnife sales—with AURYON contributing robustly in the U.S. while international sales remain a modest but growing part of the portfolio. -
Gross Margin Outlook
Q: How will tariffs and outsourcing affect margins?
A: They forecast a gross margin range of 53.5–55.5%, even after estimated tariff expenses of $4–6 million, thanks to ongoing benefits from manufacturing transfers and cost-saving initiatives. -
VTE Product Strategy
Q: What is the plan for the blood return product?
A: Management is pursuing a 510(k) regulatory process for a blood return add-on to Alphavac—designed to meet market expectations without limiting the strong performance of the current product. -
NanoKnife Reimbursement Impact
Q: Will reimbursement boost NanoKnife usage in Jan ’26?
A: The team sees the new reimbursement codes effective January 2026 as a catalyst to enhance NanoKnife capital sales alongside ongoing strong disposable adoption, setting the stage for gradual growth. -
M&A and Divestiture Strategy
Q: Will there be new acquisitions or divestitures?
A: Management intends to focus on maximizing the current portfolio’s potential without planning new acquisitions or further divestitures, ensuring sustained growth in core assets.
Research analysts covering ANGIODYNAMICS.