ELUTIA INC. Q3 FY2025 earnings call

Management Statement and Operational Highlights:

• Mission: Elutia's mission is humanizing medicine so patients can thrive without compromise, focusing on breast reconstruction.
• Breast reconstruction market: $1.5 billion market with 15%-20% postoperative infectious complications. Elutia's NXT-41x aims to address this with local antibiotic delivery.
• EluPro success: Sold to Boston Scientific for $88 million, validating the technology platform.
• Transaction with Boston Scientific: Sold EluPro and CanGaroo products, along with facility and half the workforce, improving balance sheet and operations.
• Product lines: SimpliDerm and Cardiovascular are current commercial products; SimpliDerm saw revenue uptick, Cardiovascular had strong growth with high gross margin.
• Litigation: Resolved 7 of 110 FiberCel litigation cases, now only 6 remaining with estimated liability <$1 million.

Segment Performance:

• SimpliDerm: Generated $2.4 million in revenue in Q3 2025, up 18% from Q2. Ended distribution partnership in October and now has full control.
• Cardiovascular: Generated just under $1.9 million in Q3, first full quarter with direct sales, up 68% year-over-year and 28% sequentially.
• Overall sales: $3.3 million in Q3 2025, down from $3.6 million year-ago. GAAP gross margin was 55.8% vs. 49% year-ago. Adjusted gross margin was 64% vs. 56% year-ago.

Guidance:

• NXT-41 approval expected in the second half of next year.
• NXT-41x approval expected in the first half of 2027.
• Manufacturing: Teams are working on tech transfer and process qualification for NXT-41/41x at Gaithersburg, MD facility.
• Commercialization: SimpliDerm will help build infrastructure for NXT-41x similar to how CanGaroo helped EluPro.

Risks: Not explicitly detailed in the transcript beyond general risk factors mentioned in SEC filings, but no specific risks highlighted in the provided call content.

Q: Nelson Cox asked about learnings from EluPro's development, approval, and commercial rollout.

A: Randy Mills responded that the team is crucial, learned from FDA interactions to build IP and relationships, and commercially, having commercial infrastructure like CanGaroo helped EluPro.

Q: Matt Park asked about manufacturing plans for NXT-41/41x and sustainability of cardiovascular growth.

A: Randy Mills said NXT-41/41x are manufactured in a separate GMP facility in Gaithersburg, MD with teams working on tech transfer; cardiovascular business is steady growth with high gross margins and variable expenses.