Humacyte, Inc. Q4 FY2025 earnings call

Laura Nicholson reported on the commercial launch of Symbeth, with continued U.S. market launch and international expansion. There are 27 VAC approvals for Symbeth in the U.S. and 43 VAC committees in review. Fourth quarter sales were $0.4 million. The U.S. Defense Department has dedicated funding for evaluation of Symbeth. Internationally, there was a $1.475 million purchase commitment in Saudi Arabia and a marketing authorization application submitted to Israel. Commercial adoption of CINVEST was supported by publication of papers. Progress on dialysis access program with ATEV, including V12 Phase III trial in women and plan to submit supplemental BLA. Also, coronary tissue engineered vessel (CTEV) preclinical results published and plan to advance to first in human in 2026.

Fourth quarter product sales were $0.4 million for the quarter and $1.4 million for the year. Revenue for the year ended December 31st, 2025 was $2.0 million, of which $1.4 million related to U.S. sales of 61 SymVest units, and the remainder resulted from a research collaboration. Cost of goods sold were $9.1 million and $9.7 million for the three months and the year ended December 31st, 2025, respectively. Cost of sales included a reserve of $8.9 million to reduce inventory to its net realizable value. Research and development expenses were 14.6 million for the three months ended December 31st, 2025 compared to 20.7 million for the three months ended December 31st, 2024, and were 69.3 million for the year ended December 31st, 2025 compared to 88.6 million for the year ended December 31st, 2024. Selling general and administrative expenses were $7.6 million for the three months ended December 31, 2024, compared to $7.4 million for the three months ended December 31, 2024, and were $31.2 million for the year ended December 31st, 2025 compared to $25.8 million for the year ended December 31st, 2024.

Too early to provide formal guidance. Growth is expected to be gradual. Looking at reducing cash burn rate, having reduced force last year to save on burn, and continuing to look at spend closely. Also, looking at business development opportunities.

Q: How are sites responding to the new pricing of SynVest and thoughts on year ahead within trauma adoption?

A: Positive response to $17,000 price point, higher VAC approvals and repeat usage. Timelines for VAC committees are long, but engaging with GPOs and IDNs. Can't guide for 2026 but price, long-term data, and similar outcomes to vein are impacting.

Q: Thoughts on dialysis access interim results and BLA submission?

A: Team focused on document submissions, clinical data will be key, preclinical and CMC data already approved, will schedule pre-BLA meeting, and priority designation for six-month review cycle.

Q: Talk on sales cycle in relation to SG&A?

A: Focusing on adding to sales team domestically and internationally, putative partners in Israel and Saudi, sales personnel likely provided by distributors. Once on shelf, surgeons watch first patient and then reuse.

Q: Breakdown of Q4 sales from newly onboarded vs reorders for Symbest?

A: Don't have granularity, but seeing growth to other surgeons beyond initial champion.

Q: Comments on DOD procurement and WAC approvals?

A: Anticipate DOD funding spent in 2026, including procurement and training. VAC approval time may have been affected by holidays, lower price point improving conversion from VAC approval to product on shelf.

Q: Saudi Arabia pricing and VAC approval process?

A: Not begun negotiating pricing in Saudi, expected to be higher than U.S. due to logistics. VAC approval rate was less than 50% at higher price, now over 70% with lower price.

Q: Shortfall between street expectations and comments on cash burn?

A: Hard to comment on street expectations, growth is gradual. Looking at reducing cash burn rate, having reduced force last year, and looking at business development opportunities.