Hyperfine(US:HYPR)2025-11-13 21:17Financial Performance - Total revenues for the three and nine months ended September 30, 2025, were $3.4 million and $8.3 million, respectively, compared to $3.6 million and $10.6 million for the same periods in 2024, reflecting a decrease of 5.7% and 21.8%[114] - The net loss for the three months ended September 30, 2025, was $11.0 million, a 6.7% increase from the net loss of $10.3 million in the same period of 2024[121] - The company reported a net loss of $29.9 million for the nine months ended September 30, 2025, with an accumulated deficit of $324.3 million[141] - For the nine months ended September 30, 2025, the net cash used in operating activities was $22.7 million, primarily due to a net loss of $29.7 million[154] - The company reported a net cash used in operating activities of $30.4 million for the nine months ended September 30, 2024, due to a net loss of $30.3 million[155] Sales and Market Performance - Total Swoop® system units sold were 8 units and 22 units for the three and nine months ended September 30, 2025, down from 13 units and 39 units in the same periods of 2024, indicating a decline of 38.5% and 43.6%[114] - Device sales decreased by $142 thousand, or 4.7%, for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to a decrease in units sold[122] - Total sales decreased by $206 thousand, or 5.7%, for the three months ended September 30, 2025, with total sales for the nine months down by $2.3 million, or 21.8%[122] Research and Development - Research and development expenses decreased by 31.0% to $4.0 million for the three months ended September 30, 2025, compared to $5.9 million in 2024[121] - Research and development expenses decreased by $1.8 million, or 31.0%, for the three months ended September 30, 2025, and by $3.8 million, or 21.7%, for the nine months[129] Operating Expenses - Operating expenses decreased by 16.3% to $10.8 million for the three months ended September 30, 2025, compared to $12.9 million in 2024[121] - General and administrative expenses decreased by $358 thousand, or 7.9%, for the three months ended September 30, 2025, and by $1.1 million, or 8.5%, for the nine months[131] - Sales and marketing expenses increased by $72 thousand, or 2.9%, for the three months ended September 30, 2025, and by $862 thousand, or 12.7%, for the nine months[133] Cash Flow and Financing - As of September 30, 2025, the company had cash and cash equivalents of $21.6 million, indicating ongoing negative cash flows from operations[141] - The company raised gross proceeds of $20.1 million from the October 2025 Offering, including $17.5 million from the initial offering and $2.6 million from the exercise of the Underwriter Option[147] - The net cash provided by financing activities for the nine months ended September 30, 2025, was $8.2 million, mainly from the February 2025 Offering and sales under the Sales Agreement[158] - The company experienced a net decrease in cash, cash equivalents, and restricted cash of $15.6 million for the nine months ended September 30, 2025[153] - The company plans to use cash for product development, commercial expansion, and general corporate purposes[149] Product Development and Market Expansion - The Swoop® system received 510(k) clearance for its tenth-generation AI-powered software, Optive AI™, in May 2025, which enhances image processing and reduces scan times without compromising quality[110] - The company is focusing on expanding its commercialization efforts beyond critical care to include emergency departments and neurology clinics, supported by the launch of the next-generation Swoop® system[117] - The Swoop® system has received marketing authorization in several countries, including the EU, UK, Canada, Australia, and New Zealand, facilitating international market expansion[112] Grants and Funding - The company received $4.9 million in grants from the Bill and Melinda Gates Foundation to deploy the Swoop® system in low-middle income settings, with an additional $3.4 million grant awarded in May 2023[119] Interest and Currency Exposure - Interest income decreased by $398 thousand, or 68.0%, for the three months ended September 30, 2025, and by $1.3 million, or 63.9%, for the nine months[135] - The company does not have significant exposure to foreign currencies, as most transactions are executed in U.S. dollars[171]