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01/09 20:09
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The company reported strong financial metrics with 39% YoY revenue growth and improved gross margins. Despite a net loss, the cash position is strong due to recent financing. The U.S. launch of CGuard Prime shows positive momentum with strong physician feedback. The Q&A highlighted positive sentiment and growth expectations, although management avoided specific margin guidance. Overall, the earnings call suggests a positive short-term outlook, with expected growth in the U.S. market and improved margins.
Total Revenue $2.5 million, representing year-over-year growth of 39% and sequential growth of over 40% since the last quarter. Growth was driven by strong early momentum in the U.S. and continued demand for the CGuard stent platform internationally.
U.S. Revenue $497,000, driven by the launch of CGuard Prime. This is the first quarter of U.S. commercial revenue following FDA approval in late June.
International Revenue $2.0 million, an increase of $223,000 or 12% compared to $1.8 million for the third quarter of 2024. Growth was driven by increased usage in over 30 markets and the favorable impact of foreign exchange.
Gross Profit $864,000, an increase of $450,000 or over 100% compared to $414,000 for the third quarter of 2024. This increase resulted from higher revenue and a favorable shift in sales mix towards higher-margin revenue from the U.S. commercial launch, partially offset by higher production variances and training costs.
Gross Margin 34.2% of revenue, up from 22.9% of revenue during the third quarter of 2024. The increase was driven by favorable revenue mix and volume leverage of fixed operating costs.
Total Operating Expenses $13.9 million, an increase of $5.0 million or 57% compared to $8.9 million for the third quarter of 2024. The increase was primarily due to higher headcount-related expenses and occupancy and infrastructure expenses related to the establishment of the U.S. headquarters.
Financial Income $343,000, a decrease of $229,000 compared to $572,000 in the third quarter of 2024. The decrease was due to a $118,000 decrease in financial income from investments and a $104,000 increase in financial expenses related to changes in exchange rates.
Net Loss $12.7 million or $0.17 per share, compared to a net loss of $7.9 million or $0.16 per share for the same period in 2024. The increase in net loss was due to higher operating expenses and decreased financial income.
Cash and Cash Equivalents $63.4 million as of September 30, 2025, compared to $19.4 million as of June 30, 2025. The increase was due to $40.1 million raised through a PIPE offering and $17.9 million from the exercise of milestone-based financing tranches.
CGuard Prime launch: CGuard Prime was launched in the U.S. following FDA approval in June 2025. Over 100 cases have been completed in the U.S., with strong demand and excitement from physicians and hospital systems. Globally, nearly 70,000 stents have been sold to date.
Clinical trials for new products: C-GUARDIANS II and III are advancing, with the former expected to complete enrollment by the end of 2025 and approval anticipated in mid-2026. C-GUARDIANS III is expected to launch in mid-2027. A tandem lesion study for acute stroke care is over 50% enrolled.
U.S. market entry: The company initiated commercial efforts in the U.S. in July 2025, following FDA approval of CGuard Prime. U.S. revenue for Q3 2025 was $497,000, marking the first quarter of U.S. commercial revenue.
International market growth: International revenue for Q3 2025 was $2.0 million, a 12% increase from Q3 2024, driven by increased usage in over 30 markets and favorable foreign exchange impacts.
Revenue growth: Total revenue for Q3 2025 was $2.5 million, a 39% year-over-year increase and a 40% sequential increase from the previous quarter.
Gross margin improvement: Gross margin increased to 34.2% in Q3 2025, up from 22.9% in Q3 2024, driven by a favorable sales mix and volume leverage.
Operating expenses: Operating expenses increased by 57% year-over-year to $13.9 million in Q3 2025, primarily due to higher headcount and infrastructure expenses for U.S. expansion.
Financing activities: Raised $40.1 million through a PIPE offering and $17.9 million from milestone-based warrant exercises in Q3 2025. Remaining tranches are tied to future milestones, including U.S. sales and FDA clearance for new products.
Leadership addition: Dr. Peter Soukas was appointed as Chief Medical Officer to oversee clinical and medical topics, further advancing the company's technology and awareness among physicians.
Regulatory Approvals and Timelines: The company is dependent on regulatory approvals for its products, such as the anticipated FDA clearance for the SwitchGuard TCAR neuroprotection system and the TCAR-indicated CGuard Prime stent. Delays in these approvals could impact the company's ability to launch products and achieve growth targets.
Operational Costs and Expenses: Operating expenses increased significantly by 57% year-over-year, driven by higher headcount-related expenses and infrastructure costs. This could strain financial resources if revenue growth does not keep pace.
Market Penetration Challenges: The company is in the early stages of U.S. market penetration for CGuard Prime. Challenges in achieving value analysis committee approvals, contract completions, and case initiations could slow adoption.
Economic and Currency Risks: The company experienced a $104,000 increase in financial expenses due to changes in exchange rates, which could continue to impact financial performance given its international operations.
Competitive Pressures: The carotid interventional market is competitive, and the company must establish its products as superior to alternatives. Failure to do so could limit market share.
Clinical Trial Dependencies: The company's growth strategy relies on the successful completion of clinical trials, such as C-GUARDIANS II and III. Delays or unfavorable outcomes could hinder product launches and market expansion.
Financial Sustainability: The company reported a net loss of $12.7 million for the quarter, and its financial sustainability depends on achieving milestones to unlock additional financing tranches. Failure to meet these milestones could limit cash flow.
Revenue Expectations: For the fourth quarter of 2025, the company expects revenue to be approximately $2.5 million to $3.0 million, driven by sequential growth in U.S. sales and steady demand trends internationally.
Clinical Trials and Product Approvals: The company anticipates completing enrollment for the C-GUARDIANS II study by the end of 2025, with potential approval expected in mid-2026. Additionally, FDA clearance and launch of the fully integrated TCAR solution (C-GUARDIANS III) is expected in mid-2027.
Market Expansion: The company is focused on expanding its reach in the U.S. market following the FDA approval of CGuard Prime, with plans to drive sustainable penetration and growth. The U.S. market for TCAR procedures already exceeds 30,000 annually, and the company aims to establish a competitive position in this segment.
Gross Margin Projections: The company expects continued expansion of gross margins in future quarters as U.S. commercial sales ramp up, driving favorable revenue mix and volume leverage.
Future Financing Milestones: Two remaining financing tranches are expected to be triggered by future milestones: completion of four quarters of U.S. commercial sales of CGuard Prime (anticipated in the back half of 2026) and FDA clearance for the SwitchGuard TCAR neuroprotection system along with the TCAR-indicated CGuard Prime stent (expected in 2027).
The selected topic was not discussed during the call.
The company reported strong financial metrics with 39% YoY revenue growth and improved gross margins. Despite a net loss, the cash position is strong due to recent financing. The U.S. launch of CGuard Prime shows positive momentum with strong physician feedback. The Q&A highlighted positive sentiment and growth expectations, although management avoided specific margin guidance. Overall, the earnings call suggests a positive short-term outlook, with expected growth in the U.S. market and improved margins.
The earnings call indicates a challenging financial position with increased net losses and operating expenses, alongside decreased gross margins. While there is positive momentum with the U.S. launch of CGuard Prime, adoption is gradual, and management's lack of specific guidance raises concerns. The Q&A section highlighted uncertainties in timelines and market strategies. Despite some positive developments, the overall sentiment is negative due to financial strain and unclear future prospects.
The earnings call reveals several concerns: missed earnings expectations, increased operating expenses, and a significant net loss. The lack of forward-looking revenue guidance and the delay in FDA approval for CGuard Prime add to uncertainties. Despite positive clinical trial data and a strong sales force expansion, these factors, combined with competitive pressures and supply chain challenges, create a negative outlook. The absence of share repurchase or dividend programs further limits investor appeal. Overall, the sentiment is negative, with potential for a stock price decline in the range of -2% to -8%.
The earnings call highlights several concerns: increased net loss, rising operating expenses, and lack of revenue guidance. While there is optimism for FDA approval of CGuard Prime, delays and regulatory risks pose significant challenges. The financial health is strained with decreasing cash reserves. The Q&A session revealed vague responses about FDA interactions, raising uncertainty. Despite the potential for future growth and a shareholder return plan, immediate financial pressures and uncertainties weigh heavily, suggesting a negative stock price movement in the short term.
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