For the year ending December 31, 2025, the Company is reaffirming its 2025 financial guidance as follows: Sales for the full year are estimated to be approximately $1.0 billion. Sales in the United States of approximately $700 million. Sales outside the United States of approximately $300 million, which reflects a $10 million headwind associated with the Company’s preparation for direct commercial operations in select countries in 2026. Gross margin is estimated to be approximately 53% to 54% of sales for the full year. Adjusted EBITDA margin is estimated to be approximately negative 5% of sales for the full year, recast in the second quarter of 2025 from approximately 3%.
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