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01/09 20:08
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
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.
Total Revenue $1.8 million, a 2% increase year-over-year. This increase was driven by increased usage in international markets due to the continued adoption of CGuard technology and the positive impact of foreign exchange, partially offset by decreased revenue from Russia and European distributors managing inventory levels in anticipation of the CGuard Prime launch in Europe.
Gross Profit $313,000, a decrease of $18,000 or 5.7% year-over-year. This decrease was due to an increase in some production variances, partially offset by lower material and labor costs.
Gross Margin 17.6%, a decrease from 19.0% year-over-year. This was driven by the factors affecting gross profit, including production variances and lower material and labor costs.
Total Operating Expenses $13.3 million, an increase of $4.7 million or 55% year-over-year. This increase was primarily due to higher headcount-related expenses to expand the U.S. commercial team and occupancy-related expenses for establishing a U.S. headquarters.
Net Loss $13.2 million or $0.26 per share, compared to $7.9 million or $0.22 per share year-over-year. The increase in net loss was driven by higher operating expenses and decreased financial income.
Cash and Cash Equivalents $19.4 million as of June 30, 2025, compared to $26.1 million as of March 31, 2025. This decrease does not include the $58 million in gross proceeds from recent financing events.
FDA premarket approval for CGuard Prime Carotid Stent System: Received FDA premarket approval for CGuard Prime, marking a significant milestone. The product aims to transform the carotid intervention market with a stent-first approach, targeting over 3 million global carotid artery disease patients. Early U.S. commercial launch has begun with strong interest from physicians.
C-GUARDIANS II and III pivotal studies: Progressing with studies to expand the use of CGuard Prime in TCAR procedures. C-GUARDIANS II targets FDA approval by 2026, while C-GUARDIANS III aims for a 2027 launch with a fully integrated TCAR solution.
Acute stroke care expansion: Conducting a tandem lesion early feasibility study to evaluate CGuard Prime in acute stroke patients. Enrollment is halfway complete, showcasing potential in high-risk cases.
U.S. market entry: Commenced U.S. commercial launch of CGuard Prime, leveraging experience from over 30 international markets. Early traction observed with approvals, orders, and procedures in multiple accounts.
Global market presence: Sold over 60,000 implants globally, reinforcing expertise and infrastructure. Positioned to capitalize on the U.S. carotid intervention market shift towards stenting.
Financial performance: Q2 2025 revenue increased by 2% to $1.8 million, driven by international adoption of CGuard technology. Gross profit decreased slightly due to production variances, while operating expenses rose by 55% to $13.3 million due to U.S. expansion efforts.
Funding and cash position: Raised $58 million through private placement and warrant exercises, significantly strengthening cash reserves to support U.S. commercial scale-up.
Strategic focus on stent-first approach: Positioning CGuard Prime as the go-to solution for carotid intervention, supported by clinical evidence and a comprehensive product portfolio.
Long-term growth strategy: Investing in clinical studies, U.S. market entry, and acute stroke care to drive growth and shareholder value.
Regulatory and Clinical Approval Timelines: The company anticipates FDA clearance and launch of its SwitchGuard TCAR neuroprotection system in 2027, which is subject to variability in clinical enrollment and FDA review timelines. Delays in these processes could impact the company's ability to expand its product offerings and market reach.
Operational Costs and Financial Losses: Operating expenses increased by 55% year-over-year, driven by headcount expansion and establishment of U.S. headquarters. The company reported a net loss of $13.2 million for Q2 2025, up from $7.9 million in Q2 2024, which could strain financial resources if revenue growth does not offset these costs.
Supply Chain and Inventory Management: Revenue from European distributors decreased due to inventory adjustments in anticipation of the CGuard Prime launch in Europe. This indicates potential challenges in managing supply chain and inventory levels during product transitions.
Market Adoption and Commercial Launch Risks: The company is in the early stages of its U.S. commercial launch for CGuard Prime. While initial interest is strong, the adoption trajectory is expected to be gradual, and success depends on navigating value analysis committee approvals and educating providers.
Foreign Exchange and Financial Income Volatility: Financial income decreased due to unfavorable changes in exchange rates and reduced income from investments, which could impact overall financial stability.
U.S. Commercial Launch of CGuard Prime: The company has commenced the U.S. commercial launch of its CGuard Prime Carotid Stent System, leveraging experience from over 30 international markets. Early interest has been strong, with approvals, orders, and commercial procedures completed in numerous accounts and hospital systems. The company is building traction and velocity to create and capture market demand.
Clinical Pipeline and TCAR Studies: The company is advancing pivotal studies, including C-GUARDIANS II and C-GUARDIANS III, to strengthen its competitive position in the TCAR market. FDA approval for C-GUARDIANS II is expected in the first half of 2026, while clearance and launch for C-GUARDIANS III are anticipated in 2027.
Expansion into Acute Stroke Care: The company is conducting a tandem lesion early feasibility study in partnership with the Jacobs Institute. Enrollment is halfway complete, and the study evaluates the use of CGuard Prime in acute stroke patients with tandem lesions.
Financial Position and Future Financing Milestones: The company raised $58 million in gross proceeds through recent financing events, significantly strengthening its cash position. Additional financing tranches are tied to milestones, including four quarters of U.S. commercial sales of CGuard Prime (expected in the back half of 2026) and FDA clearance for the SwitchGuard TCAR neuroprotection system.
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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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