Axogen, Inc reports 2023 Q4 and full-year financial results

Axogen, Inc. reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2023.

Fourth quarter 2023 financial results and business highlights

• Fourth quarter revenue was $42.9 million, an 18.7% increase compared to the fourth quarter of 2022.
• The Company estimates that revenues from emergent trauma procedures represented approximately half of total revenues during the fourth quarter and grew mid-single digits versus the fourth quarter of 2022.
• The Company estimates that revenues from scheduled non-trauma procedures represented approximately half of total revenues during the fourth quarter and grew more than 25% versus the fourth quarter of 2022.
• Gross margin was 78.7% for the fourth quarter compared to 83.0% in the fourth quarter of 2022.
• Net loss for the quarter was $3.9 million, or $0.09 per share, compared to net loss of $5.4 million, or $0.13 per share in the fourth quarter of 2022.
• Adjusted net loss for the quarter was $2.6 million, or $0.06 per share, compared to adjusted net loss of $1.1 million, or $0.03 per share in the fourth quarter of 2022.
• Adjusted EBITDA was $0.6 million for the quarter, compared to an adjusted EBITDA loss of $0.7 million in the fourth quarter of 2022.
• The balance of all cash, cash equivalents, and investments on December 31, 2023 was $37.0 million, as compared to a balance of $38.6 million on September 30, 2023.

“We are pleased with our solid performance in the fourth quarter, and we are encouraged by the continued momentum we’ve seen in this first quarter,” commented Karen Zaderej, chairman, CEO, and president of Axogen, Inc. “Looking ahead, we remain focused on further penetrating core accounts by leveraging our growing body of clinical evidence and expanding use cases with our innovative new products and applications. Additionally, we are excited to expand our leadership position in nerve repair with the 2024 Q2 launch of Avive+ Sofit Tissue Matrix, supporting our mission of restoring nerve function and quality of life to patients with peripheral nerve injuries.”

Full-year financial results and business highlights

• Full-year 2023 revenue was $159.0 million, a 14.7% increase compared to 2022 revenue of $138.6 million.
• Revenue from Core Accounts represents approximately 65% of total revenue.
• Gross margin was 80.4% for the full-year, compared to 82.6% in 2022.
• Net loss for the year was $21.7 million, or $0.51 per share, compared to net loss of $28.9 million, or $0.69 per share in 2022.
• Adjusted net loss was $7.3 million for the full-year, or $0.17 per share, compared to 12.6 million for the full-year, or $0.30 per share in 2022.
• Adjusted EBITDA loss was $1.1 million for the full-year, compared to an adjusted EBITDA loss of $9.3 million for 2022.
• Core Accounts totaled 376, a 13.3% growth over the prior year level of 332.
• Ended the fourth quarter with 116 direct sales representatives compared to 116 at the end of the third quarter and 115 on December 31, 2022.

Summary of operational and business highlights

• We recently completed a productive Pre-BLA meeting with FDA. We have aligned with FDA on a rolling submission process and the content of the modules for submission. We anticipate the filing to be completed in the third quarter of 2024. Subject to ongoing engagement with FDA, we currently believe the submission timetable will allow for a potential approval in mid-2025.
• In August 2023, we began processing tissue in the new, state-of-the-art biologics processing facility, which provides for up to three times the previous capacity and was designed for long-term growth and expansion.
• During 2023, we surpassed 100,000 Avance nerve graft implants since launch in 2007.
• We are continuing to expand our offering in the nerve protection market with the national launch of Axoguard HA+ Nerve Protector™ in 2023 and expect to launch Avive+ Soft Tissue Matrix™ in the second quarter of 2024.
• We launched Resensation^® for implant-based reconstruction allowing us to access an additional 10-15% of the overall breast reconstruction market. As part of this launch, we have established a comprehensive training program to support the adoption of this innovative approach to bring sensation to more patients undergoing mastectomy.
• We ended the year with 245 peer-reviewed clinical publications featuring Axogen’s nerve repair product portfolio.

2024 financial guidance
We expect revenue to be in the range of $177 million to $181 million, which represents an annual growth rate of approximately 11% to 14%. Additionally, we anticipate gross margin for the full year to be in the range of 76% to 79%.
MB Bureau