ELUTIA INC. Q4 FY2024 earnings call

• Company Mission: Elutia Inc.'s mission is to humanize medicine by pioneering drug loading biometrics to help patients thrive without compromise.
• Platforms: Two main platforms - EluPro (FDA-cleared for cardiac implantable electronic devices and neurostimulators) and Simpliderm (used in breast reconstruction).
• Strategy: Focused strategy includes proving EluPro's commercial value, growing Simpliderm, and expanding drug eluting biologics to other product lines.
• EluPro Pilot Launch: Exceeded expectations in operational excellence, hospital/GPO approval, and clinical uptake. Q4 EluPro accounted for 30% of bio envelope sales, with sales increasing 65% when switching to EluPro centers.
• Partnerships: Partnering with Boston Scientific for EluPro distribution to leverage their 900 reps.
• Simpliderm Impact: Affected by Sientra's bankruptcy and acquisition by Tiger Aesthetics, but still saw 12% year-to-date growth despite Q4 disruption.

Device Protection: In the fourth quarter, device protection sales (including EluPro and Kangaroo) were $2.7 million, up 18% quarter-over-quarter. Year-to-date, it was $9.9 million, up 5% year-over-year. Gross margin for this segment was 60%.

Simpliderm: Fourth quarter sales were $2.3 million, down year-over-year. Year-to-date, it was $11.6 million, up 12% year-over-year. Gross margin was 55%.

Cardiovascular: Fourth quarter sales were $0.5 million, down quarter-over-quarter. Year-to-date, it was $2.4 million, down 1% year-over-year. Gross margin was 64%.

Overall: Total revenue for the fourth quarter was $5.5 million, down 7% quarter-over-quarter. Year-to-date revenue was $24.4 million, down 1% year-over-year. GAAP gross margin was 43%, while non-GAAP gross margin (excluding intangible amortization) was 58%. Operating expense was $10.8 million in the fourth quarter, resulting in a loss from operations of $8.4 million. Adjusted EBITDA loss was $3.8 million for the quarter, an improvement from the prior year. Cash at the end of the quarter was $13.2 million.

• EluPro pilot launch exceeded expectations, and adoption is expected to accelerate in Q1 2025 with Boston Scientific partnership.
• Simpliderm is expected to continue as a growth driver in 2025, though Q4 disruption was an anomaly.

• Litigation settlements in Q4 affected cash usage.
• Dependence on VAC and GPO approvals for EluPro adoption.
• Disruption from Sientra's bankruptcy and transition to Tiger Aesthetics impacting Simpliderm sales.

Q: Discuss to what extent Boston will be involved with EluPro in terms of distribution and marketing equity.

A: Elutia partners with Boston Scientific to leverage their 900 reps to distribute EluPro. Boston reps help get into hospitals and facilitate usage, with Elutia paying a nominal commission per EluPro usage.

Q: Talk through the cadence of expectations around new account additions for EluPro throughout 2025.

A: Currently adding about 15 accounts per month, but pace may slow due to VAC cycle times and varying approval speeds, though partnership with Boston Scientific will help pull in more accounts.

Q: Discuss the cash burn in the quarter and litigation expectations for 2025.

A: Q4 cash usage was due to litigation settlements. Litigation liability decreased from $20 million at end of Q3 to $15.9 million at year-end, with fewer cases remaining, and activity expected to decline in 2025 but some remaining work still to be done.