• BioEnvelope Sales: $2.7 million for the quarter, an 18% growth over the same quarter of the prior year.
• Full Year BioEnvelope Sales: $9.9 million, reflecting a 5% growth year-over-year.
• SimpliDerm Sales: $2.3 million for the quarter, down year-over-year; $11.6 million for the full year, up 12% year-over-year.
• Cardiovascular Sales: $0.5 million for the quarter, compared to $600,000 in the prior year quarter.
• Total Revenue: $5.5 million for the quarter, down 7% year-over-year; $24.4 million for the full year, down 1% from the prior year.
• Gross Margin: 43% for the quarter, up from 36% in the prior year; 58% excluding non-cash amortization, up from 51% in the prior year.
• Operating Expenses: $10.8 million for the quarter, consistent with $10.6 million in the prior year.
• Loss from Operations: $8.4 million for the quarter, compared to $8.5 million in the prior year.
• Adjusted EBITDA: Loss of $3.8 million for the quarter, improved from a $4.5 million loss in the prior year.
• Cash Position: $13.2 million at the end of the quarter.
• Post-Quarter Cash Raise: $15 million raised in gross proceeds through a registered direct offering in early February.

• Warning! GuruFocus has detected 6 Warning Signs with ELUT.

Release Date: March 06, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Elutia Inc (NASDAQ:ELUT) successfully launched its EluPro product, receiving FDA clearance for use in cardiac implantable electronic devices and neurostimulators.
• The company demonstrated operational excellence by completing an FDA site inspection with no deficiencies and commenced commercial production.
• Elutia Inc (NASDAQ:ELUT) achieved significant growth in its BioEnvelope sales, with an 18% increase in the fourth quarter.
• The company secured 67 hospital and GPO approvals, surpassing its initial goal of 25, indicating strong market acceptance.
• Elutia Inc (NASDAQ:ELUT) raised $15 million in gross proceeds through a registered direct offering, strengthening its cash position.

Negative Points

• SimpliDerm product sales experienced a decline in the fourth quarter, attributed to disruptions from Sientra's bankruptcy.
• Overall revenue for the quarter was down 7% compared to the same quarter of the prior year.
• The company reported a loss from operations of $8.4 million, consistent with the previous year.
• Cash usage was higher than in recent quarters due to settling outstanding lawsuits, impacting the cash balance.
• Elutia Inc (NASDAQ:ELUT) faces ongoing litigation challenges, with 43 cases still unresolved at the end of the year.

Q & A Highlights

Q: Can you discuss the extent of Boston Scientific's involvement in the distribution of EluPro? A: C. Randall Mills, President, CEO, and Director of Elutia Inc, explained that Elutia has an agreement with Boston Scientific for the distribution of EluPro in the United States. Boston's 900 reps will partner with Elutia's territory managers to access hospitals and facilitate the use of EluPro, especially in centers that are less frequently visited. This partnership helps keep Medtronic's TYRX envelope out of their cases, and Boston reps receive a nominal commission for each EluPro usage.

Q: When will Boston Scientific commence distribution of EluPro? A: C. Randall Mills stated that the distribution by Boston Scientific will commence shortly. He emphasized that Elutia has managed the current demand with its resources, highlighting the product's value and the strategic advantage of not being a pacemaker manufacturer, which makes Elutia a non-threatening partner to other companies.

Q: How should we think about utilization at accounts, particularly high-volume versus low-volume accounts? A: Matthew Ferguson, CFO of Elutia Inc, noted that high-volume accounts typically have annual usage in the hundreds. There are about 1,400 accounts in the U.S. with over 100 pacemaker and defibrillator procedures annually, and about 500 accounts with over 500 procedures. Elutia is seeing growth in EluPro usage, with many TYRX users switching to EluPro.

Q: Can you elaborate on the deceleration in SimpliDerm's growth during the fourth quarter and the plan for 2025? A: C. Randall Mills explained that SimpliDerm is distributed through independent distributors and a partnership with Sientra, which went into bankruptcy, causing disruption. The assets were acquired by Tiger Aesthetics, and Elutia is working through the transition. Despite the fourth quarter slowdown, SimpliDerm grew 12% over the year, and Elutia is optimistic about resolving the issues and achieving growth in 2025.

Q: Is there potential to establish distribution agreements with other pacemaker companies beyond Boston Scientific? A: C. Randall Mills confirmed that Elutia has the flexibility to establish agreements with other pacemaker companies. However, the current demand from Elutia's team and Boston Scientific is substantial, and strategic considerations will guide any future partnerships.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.