0001688757-25-000065
SEC filingRevenue grew 20.6% to $146.5M in 9M25, driven by US launch; gross margin expanded to 68.8% as higher US prices lifted profitability.
For the nine months ended September 30, 2025, revenue increased 20.6% to $146.5 million from $121.5 million in the prior-year period, driven primarily by the commercial launch of Motiva Implants in the United States following FDA approval in September 2024. Gross profit rose to $100.8 million (68.8% margin) from $79.0 million (65.0% margin), with margin expansion attributed to higher selling prices in the US market. Operating expenses increased 23.2% to $135.9 million, largely due to a 26.3% rise in SG&A to $121.0 million, reflecting investments in sales infrastructure, personnel, and marketing to support US commercialization. R&D expense was relatively flat at $14.8 million. Net loss improved to $48.4 million from $50.1 million, aided by a $10.4 million swing in other income/expense, primarily from favorable foreign currency movements. Interest expense increased to $18.0 million from $14.9 million due to higher debt principal.
Geographic performance varied significantly. North America was the standout, with US sales of $28.3 million in 9M25, driven by strong surgeon adoption and over 1,300 accounts. Latin America grew 4.4% year-over-year, with Brazil stabilizing and Argentina seeing strong growth. EMEA revenue increased 5.6%, benefiting from improved demand in direct markets. Asia-Pacific declined 22.5%, primarily due to the China distributor selling through inventory purchased in fiscal 2024, coupled with lower consumer demand for aesthetic procedures. Management remains focused on establishing Motiva as the leading implant in China.
Management expects overall operating expenses to rise in 2025 compared to 2024 due to increased commercial and operational activities following US approval, though they remain focused on expense management. The company highlighted that higher US selling prices positively impacted gross margins in 2025. No specific quantitative guidance was provided. Key strategic priorities include expanding the US market, launching Preservé in additional countries, and continuing the Mia Femtech rollout. The post-approval study (PAS) is underway, with estimated costs of $4-5 million over ten years. Liquidity is expected to be sufficient for at least 12 months, supported by $70.6 million cash and access to $10 million in inventory financing.
Cash and cash equivalents decreased to $70.6M from $90.3M at year-end 2024, driven by operating cash use of $50.7M. Total debt increased to $256.5M (Oaktree note $246.5M net and $10M short-term notes). Shareholders' equity fell sharply to $16.4M from $53.1M due to net loss and foreign currency translation losses. Inventory rose to $88.2M (consignment $13.5M) with a $5.9M obsolescence reserve. Allowance for credit losses doubled to $6.0M.
No material purchase commitments are disclosed. The company has an option to buy land for $2.8M and an inventory funding agreement capped at $10M (drawn $10M). Contingent consideration from the Benelux acquisition is $0.9M. Operating lease liabilities total $4.7M, with remaining lease payments of $5.7M.
No share buybacks or dividends. Debt activity: in September 2025, the company drew the $25M Tranche D term loan under the Oaktree facility (net $24.5M after discount) and $10M under the inventory funding agreement. Capex was $4.2M for property/equipment and $0.8M for intangible assets, totaling 3.4% of revenue.
The company reports one segment but provides revenue by geography. For the nine months ended September 30, 2025: EMEA $64.5M (+5.6% YoY), Latin America $28.3M (+4.5%), Asia-Pacific $25.4M (-22.5%), North America $28.2M (vs $0.5M in 2024, reflecting U.S. FDA approval). The U.S. contributed 19.4% of consolidated revenue.