InspireMD Inc’s Earnings Call: Growth Amid Challenges

InspireMD Inc ((NSPR)) has held its Q1 earnings call. Read on for the main highlights of the call.

InspireMD Inc’s recent earnings call presented a balanced narrative of progress and hurdles. The company reported growth in CGuard revenue and advancements in clinical trials, alongside strategic commercial preparations. However, these positive strides were tempered by increased operating expenses, a higher net loss, and anticipated delays in FDA approval. Despite these challenges, the potential U.S. market opportunity and strategic progress offer a sense of optimism.

CGuard Revenue Growth

CGuard revenue reached $1.53 million, reflecting a modest 1.2% growth year-over-year with 2,611 stents sold. This growth, although slight, indicates a steady demand for the product and contributes to the company’s overall revenue stream.

U.S. Market Opportunity

The potential revenue for CGuard Prime in the U.S. market is estimated at $12 million, based on current international sales volumes. This highlights a significant opportunity for InspireMD to expand its market presence and revenue base once FDA approval is secured.

Clinical Pipeline Progress

InspireMD is making strong strides in its clinical pipeline, with robust enrollment in the C-GUARDIANS II study and the first patients enrolled in the Tandem Lesion Early Feasibility Study. These developments are crucial for the company’s long-term growth and product validation.

Commercial Launch Preparations

The company is gearing up for its U.S. operations by onboarding 20 sales and marketing professionals and establishing a facility in Miami. These steps are vital for the successful commercial launch of CGuard Prime, positioning InspireMD for future growth.

Increased Operating Expenses

Operating expenses for Q1 2025 increased by $4 million or 52.5% compared to Q1 2024. This rise is primarily attributed to expansion-related costs, reflecting the company’s investment in future growth and market expansion.

Net Loss Increase

InspireMD reported a net loss of $11.166 million for Q1 2025, up from $7.032 million in Q1 2024. This increase underscores the financial challenges the company faces as it invests in its growth initiatives.

Decline in Cash and Equivalents

The company’s cash and cash equivalents decreased from $34.637 million as of December 31, 2024, to $26.086 million as of March 31, 2025. This decline reflects the financial impact of the company’s expansion efforts and increased operating expenses.

FDA Approval Delays

InspireMD anticipates a delay in FDA approval for CGuard Prime to Q3 2025 due to site audit and regulatory feedback timing. This delay poses a challenge but also sets a clear timeline for the company’s strategic planning.

Forward-Looking Guidance

InspireMD remains optimistic about the future, with expectations for FDA approval of CGuard Prime in Q3 2025, potentially generating $12 million in U.S. revenue. The company is advancing its clinical pipeline, with the C-GUARDIANS II pivotal study progressing well and approval anticipated in the first half of 2026. InspireMD is also preparing for the U.S. launch with a dedicated team of sales and marketing professionals.

In summary, InspireMD’s earnings call highlighted a mix of growth and challenges. While the company faces increased expenses and approval delays, its strategic initiatives and market opportunities provide a promising outlook. Investors and stakeholders will be keenly watching how InspireMD navigates these dynamics in the coming quarters.