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Elutia (ELUT) investor relations material

Elutia Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary6 Nov, 2025

Executive summary

  • Completed $88 million sale of BioEnvelope/CIED business to Boston Scientific, with $80–$80.3 million received at closing and $8 million in escrow, reported as discontinued operations and used to eliminate debt and fund NXT-41/41x development.

  • Focus shifted to Women's Health and Cardiovascular segments, advancing NXT-41 and NXT-41x, next-generation antibiotic-eluting matrices targeting a $1.5 billion U.S. breast reconstruction market with significant unmet needs.

  • Regained full operational control and direct sales channels for SimpliDerm and Cardiovascular product lines after terminating distribution partnerships.

  • Commercial infrastructure and resources are being built to support product approval and launch.

  • Substantially resolved legacy FiberCel litigation, reducing expected future legal expenses, with six cases and estimated liability under $1 million remaining.

Financial highlights

  • Q3 2025 net sales from continuing operations were $3.3 million, down from $3.6–$3.7 million year-over-year, but up sequentially in key segments.

  • SimpliDerm revenue was $2.4 million, down 23% year-over-year but up 18% sequentially; Cardiovascular revenue was $0.9 million, up 68% year-over-year and 28% sequentially.

  • GAAP gross margin improved to 55.8% from 48.9%; adjusted gross margin rose to 63.9% from 56.3%.

  • Operating expenses decreased to $7.1 million from $11 million year-over-year; loss from operations narrowed to $5.2 million from $9.2 million.

  • Adjusted EBITDA loss was $2.7 million for the quarter, similar to the prior year.

Outlook and guidance

  • $80 million in cash received post-quarter from the Boston Scientific transaction, with $8 million in escrow, providing sufficient runway for development, approval, and commercialization of NXT-41 and NXT-41x through 2027.

  • NXT-41 (matrix only) expected to receive FDA clearance in the second half of 2026; NXT-41x (antibiotic-eluting) targeted for approval in the first half of 2027.

  • Company expects continued operating losses and negative cash flows as it invests in product development and commercialization.

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Frequently asked questions

Elutia Inc., formerly known as Aziyo Biologics, Inc., is a commercial-stage company that focuses on developing and commercializing drug-eluting biomatrix technology to improve surgical outcomes. This technology is applied in products such as the CanGaroo Envelope, which is used to stabilize implantable cardiac devices like pacemakers and defibrillators, and SimpliDerm Acellular Dermal Matrix, which is utilized primarily in breast reconstruction following mastectomy. Elutia's mission revolves around humanizing medicine to ensure patients can thrive without the compromise, addressing the challenges associated with medical device implant failures and post-surgical complications. By integrating drug-eluting biologic technology with natural biologic material and extended antibiotic release, Elutia aims to optimize device implantation and soft tissue reconstruction, ensuring implant stability and promoting wound healing. Elutia Inc. is headquartered in Silver Spring, Maryland, and its shares are listed on the NASDAQ.

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