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01/10 23:51
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reflects positive sentiment, with strong financial performance, increased revenue guidance, and optimistic growth in various segments like thrombectomy and embolization. The Q&A highlights favorable reception of clinical data and minimal impact from tariffs. However, conservative Q4 guidance and lack of clarity on FDA approval specifics slightly temper expectations. Overall, the company's strategic initiatives and market position suggest a positive outlook for stock price movement.
Total Revenue $354.7 million, representing underlying year-over-year growth of 17.8% on a reported basis and 16.9% on a constant currency basis. The growth reflects broad-based execution against strategy and significant progress in enhancing competitive technological and market positioning.
Total U.S. Revenue $275 million, an increase of 21.5% compared to the third quarter of 2024. Growth driven by thrombectomy sales and embolization/access revenue.
U.S. Thrombectomy Sales $192 million, increased 18.5% year-over-year. Growth attributed to clinical benefits and competitive strength of CAVT technology alongside enhanced commercial focus.
U.S. Embolization and Access Revenue $83 million, increased 29.2% year-over-year. Growth exceeded expectations due to a dedicated peripheral embolization sales team and investment in innovation and new product introductions.
Total International Revenue $79.7 million, increased 6.6% year-over-year or 3% in constant currency. Growth offset by China growth comp headwinds but supported by portfolio and geographic strength.
Gross Margin 67.8%, expanded 130 basis points over the prior year period. Growth driven by favorable regional mix, product mix, and productivity improvements.
Operating Income $48.8 million or 13.8% of revenue, compared to $40.3 million or 13.4% of revenue in the same period last year. Growth reflects the impact of embolization sales force build-out.
Adjusted EBITDA $66.7 million or 18.8% of total revenue, compared to $56.7 million or 18.8% in the third quarter last year. Growth supported by profitability and operational leverage.
Cash, Cash Equivalents, and Marketable Securities $470.3 million, an increase of $45.7 million sequentially. Growth includes improving working capital ratios and strong profitability.
FDA clearance for Lightning Bolt 16 and Lightning Flash 3.0: These products enhance the CAVT portfolio, targeting over 800,000 U.S. patients with VTE and arterial clot issues.
Ruby XL launch: Successful launch contributed to 21.2% sequential growth in embolization revenue.
Thunderbolt submission: Responses to FDA questions submitted, aiming to introduce CAVT to the neurovascular field.
U.S. revenue growth: Total U.S. revenue increased by 21.5% year-over-year, driven by thrombectomy and embolization sales.
International revenue growth: International revenue grew by 6.6% year-over-year, overcoming China growth headwinds.
Gross margin improvement: Gross margin increased to 67.8%, with a target of over 70% by 2026.
Sales team expansion: Added 50+ peripheral embolization sales reps, driving growth in embolization revenue.
STORM-PE trial results: Proved CAVT superior to standard care for PE, with significant long-term functional improvements.
Patent defense: Secured a legal victory affirming the validity of CAVT-related patents.
Regulatory Challenges: The company is in the process of addressing final questions and clarifications from the FDA regarding the Thunderbolt 510(k) review process. This regulatory hurdle could delay the introduction of CAVT to the neurovascular field.
Market Trends in Neurovascular Business: The U.S. stroke market showed a slight decline in the third quarter, which could impact the growth and performance of the company's neurovascular business.
China Growth Headwinds: The company continues to face growth headwinds in China, which could affect its international revenue performance.
Operational Costs: The company has made significant investments in expanding its sales teams and product development, which has increased SG&A expenses. This could pressure operating margins if revenue growth does not keep pace.
Competitive Pressures: The company is actively defending its patents and intellectual property for CAVT technology, indicating ongoing competitive pressures in the market.
Economic Uncertainties: The company’s financial performance could be impacted by broader economic uncertainties, as implied by the cautionary statements regarding forward-looking projections.
Revenue Guidance: The company has raised its revenue guidance for 2025 to $1.375 billion to $1.380 billion, reflecting strong business trends and market performance.
U.S. Thrombectomy Growth: The company reiterates 20% to 21% year-over-year growth for 2025 in the U.S. thrombectomy segment.
Gross Margin Expansion: The company expects to achieve a gross margin profile of over 70% by the end of 2026, with operating margin expansion outpacing gross margin expansion in the foreseeable future.
Peripheral Embolization Business: The company anticipates sustainable growth in the U.S. embolization franchise, supported by a dedicated sales team and new product launches like Ruby XL.
Thunderbolt Product Launch: The company is optimistic about introducing Thunderbolt to the neurovascular field, which is expected to catalyze growth in the stroke market.
STORM-PE Trial Impact: The STORM-PE trial results are expected to act as a major catalyst in positively impacting the treatment of pulmonary embolism (PE) and increasing the number of patients receiving intervention with CAVT technology.
Market Trends in Neurovascular Business: The company is optimistic about market growth driven by innovation, particularly with the anticipated introduction of Thunderbolt.
Long-Term Strategy: The company remains confident in its long-term strategy focused on innovation, data generation, and team investment to support durable, profitable growth.
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The earnings call reflects positive sentiment, with strong financial performance, increased revenue guidance, and optimistic growth in various segments like thrombectomy and embolization. The Q&A highlights favorable reception of clinical data and minimal impact from tariffs. However, conservative Q4 guidance and lack of clarity on FDA approval specifics slightly temper expectations. Overall, the company's strategic initiatives and market position suggest a positive outlook for stock price movement.
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