InspireMD Inc ((NSPR)) has held its Q2 earnings call. Read on for the main highlights of the call.
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InspireMD Inc. recently held its earnings call, which was marked by a mix of optimism and caution. The company celebrated significant achievements, including FDA approval for its CGuard Prime Carotid Stent System and successful fundraising efforts, which position it for growth in the U.S. market. However, these positive developments were tempered by financial challenges, such as increased operating costs, a widened net loss, and delays in product launches.
FDA Premarket Approval for CGuard Prime Carotid Stent System
InspireMD achieved a major milestone with the FDA premarket approval for its CGuard Prime Carotid Stent System. This approval is a pivotal moment in the company’s history, allowing it to commence the U.S. commercial launch, which is expected to significantly impact its market presence.
Strong Early Interest in U.S. Market
Following the FDA approval, InspireMD has witnessed strong early interest in the U.S. market. The company has completed approvals, orders, and commercial procedures in numerous U.S. accounts and hospital systems, indicating robust demand for its products.
Successful Fundraising Efforts
InspireMD successfully raised $58 million through a private placement and the exercise of warrants. This substantial boost to its cash position is intended to support the U.S. launch and drive long-term profitability.
Growing Global Presence
Globally, InspireMD has sold over 60,000 CGuard implants, reinforcing its expertise and the strength of its global commercial infrastructure. This international experience is expected to aid in its U.S. market expansion.
Decreased Revenue and Gross Profit
The company reported a modest 2% increase in total revenue to $1.8 million, but gross profit decreased by 5.7% compared to the previous year. This decline was attributed to increased production variances and reduced revenue from Russia and European distributors.
Increased Operating Expenses
Operating expenses surged by 55% to $13.3 million in Q2 2025, primarily due to increased headcount-related expenses and the establishment of a U.S. headquarters. This rise in expenses reflects the company’s strategic investments in its U.S. operations.
Net Loss
InspireMD reported a net loss of $13.2 million for the second quarter of 2025, up from $7.9 million in the same period of 2024. This increase in net loss highlights the financial challenges the company faces amid its expansion efforts.
Delayed Launch of SwitchGuard
The launch of the SwitchGuard TCAR device has been delayed to 2027, indicating potential setbacks in the clinical and regulatory process. This delay could impact the company’s timeline for expanding its product offerings.
Forward-Looking Guidance
InspireMD’s forward-looking guidance reflects its strategic focus on transforming carotid intervention. The company aims to address the needs of over 3 million people globally diagnosed with carotid artery disease, with only 155,000 treated annually in the U.S. InspireMD is leveraging its international experience to execute its U.S. commercial playbook, engaging with numerous U.S. centers. Financially, the company has bolstered its resources to support growth and commercialization efforts, despite reporting a net loss.
In summary, InspireMD’s earnings call presented a balanced view of its current position and future prospects. While the company celebrates significant achievements like FDA approval and strong fundraising, it also faces financial challenges and delays in product launches. Investors and stakeholders will be keenly watching how InspireMD navigates these challenges to capitalize on its growth opportunities in the U.S. market.