Hyperfine(HYPR) - 2024 Q1 - Quarterly Results

Executive Summary Hyperfine reported a strong Q1 2024, achieving commercial progress, clinical milestones, and product innovation with spending discipline Q1 2024 Performance Overview Hyperfine achieved strong Q1 2024 commercial progress, clinical milestones, and product innovation, maintaining spending discipline - CEO Maria Sainz expressed satisfaction with the strong start to 2024, highlighting commercial progress in US and international markets, and key Q1 milestones[3] - The company's three core value drivers—Commercialization, Clinical Evidence, and Innovation—were successfully delivered upon in Q1 with strong spending discipline[3] Business Update Hyperfine advanced clinical studies, launched AI software, expanded internationally, and gained visibility for its portable brain imaging system Recent Achievements and Business Highlights Hyperfine achieved Q1 2024 milestones, including advancing clinical studies, launching AI software, and expanding international commercial reach - Initiated enrollment of CARE PMR study to assess the clinical utility of the Swoop® System for detecting ARIA in Alzheimer's patients receiving amyloid-targeting therapy[7] - Exceeded 100 patients enrolled in ACTION PMR, an observational study for acute ischemic stroke detection using portable brain imaging[7] - Launched 8th generation AI-powered brain imaging software, enhancing image quality and ease-of-use[7] - Appointed distributors in key EU markets to support international commercial expansion[7] - The portable Swoop Brain MR was prominently featured at key conferences, with four abstracts at the International Stroke Conference and 17 at the International Society for Magnetic Resonance Medicine[7] Company and Product Description Hyperfine developed the FDA-cleared portable Swoop® system, an ultra-low-field MRI for accessible bedside brain imaging globally - Hyperfine, Inc. developed the Swoop® system, the first FDA-cleared portable, ultra-low-field, magnetic resonance brain imaging system[8] - The Swoop® system received initial U.S. FDA clearance in 2020 and is approved for brain imaging in several countries, including Canada, Australia, the UK (UKCA certified), and the EU (CE certified), and is also available in New Zealand[8] - The company's mission is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging and data solutions, bringing brain imaging to the patient's bedside[9] Financial Performance Hyperfine reported a 25% Q1 2024 revenue increase, improved gross margin, reduced expenses, and provided full-year 2024 guidance First Quarter 2024 Financial Results Hyperfine reported a 25% Q1 2024 revenue increase to $3.30 million, driven by 13 Swoop® system sales, improving gross margin and reducing net loss Q1 2024 Financial Highlights | Metric | Q1 2024 (in millions) | Q1 2023 (in millions) | Change (%) | | :----- | :-------------------- | :-------------------- | :--------- | | Revenue | $3.30 | $2.64 | 25% | | Gross Margin | $1.35 | $1.16 | 16.4% | | R&D Expenses | $5.57 | $5.46 | 2.0% | | SG&A Expenses | $6.43 | $8.73 | -26.3% | | Net Loss | $(9.85) | $(12.16) | -19.0% | | Net Loss per Share | $(0.14) | $(0.17) | -17.6% | - Hyperfine, Inc. sold 13 commercial Swoop® systems in the first quarter of 2024[7] Condensed Consolidated Statements of Operations and Comprehensive Loss Q1 2024 total sales increased to $3.295 million, primarily from device sales, with improved gross margin and a net loss of $9.848 million Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Q1 2024 | Q1 2023 | YoY Change | | :-------------------- | :------ | :------ | :--------- | | Sales | | | | | Device | $2,704 | $2,132 | +26.8% | | Service | $591 | $503 | +17.5% | | Total Sales | $3,295| $2,635| +25.0% | | Cost of Sales | | | | | Device | $1,499 | $1,071 | +40.0% | | Service | $442 | $409 | +8.1% | | Total Cost of Sales| $1,941| $1,480| +31.1% | | Gross Margin | $1,354| $1,155| +17.2% | | Operating Expenses| | | | | Research and development| $5,570 | $5,461 | +2.0% | | General and administrative| $4,430 | $6,182 | -28.3% | | Sales and marketing | $2,004 | $2,547 | -21.4% | | Total Operating Expenses| $12,004| $14,190| -15.4% | | Loss from operations| $(10,650)| $(13,035)| -18.3% | | Interest income | $796 | $869 | -8.4% | | Net loss | $(9,848)| $(12,160)| -19.0% | | Net loss per common share| $(0.14)| $(0.17)| -17.6% | Condensed Consolidated Balance Sheets Total assets decreased to $85.443 million by March 31, 2024, primarily due to reduced cash, with stockholders' equity at $75.638 million Condensed Consolidated Balance Sheets (in thousands) | Metric | March 31, 2024 | December 31, 2023 | Change | | :-------------------- | :------------- | :---------------- | :----- | | ASSETS | | | | | Cash and cash equivalents | $63,204 | $75,183 | $(11,979) | | Total current assets | $79,690 | $88,908 | $(9,218) | | Total assets | $85,443 | $94,199 | $(8,756) | | LIABILITIES | | | | | Total current liabilities | $8,767 | $8,768 | $(1) | | Total liabilities | $9,805 | $9,800 | $5 | | STOCKHOLDERS' EQUITY| | | | | Accumulated deficit | $(263,570) | $(253,722) | $(9,848) | | Total stockholders' equity| $75,638| $84,399 | $(8,761) | Condensed Consolidated Statement of Cash Flows Q1 2024 net cash used in operating activities was $12.510 million, resulting in an end-of-period cash balance of $63.204 million Condensed Consolidated Statement of Cash Flows (in thousands) | Metric | Q1 2024 | Q1 2023 | Change | | :-------------------- | :------ | :------ | :----- | | Net cash used in operating activities | $(12,510) | $(13,491) | $981 | | Net cash used in investing activities | $(145) | $(61) | $(84) | | Net cash provided by financing activities | $55 | $49 | $6 | | Net decrease in cash and cash equivalents and restricted cash | $(12,600)| $(13,503)| $903 | | Cash, cash equivalents and restricted cash, end of period | $63,204 | $104,740 | $(41,536) | 2024 Financial Guidance Management expects full-year 2024 revenue between $12 million and $15 million and a cash burn of approximately $40 million - Management expects full-year 2024 revenue to be $12 million to $15 million[7] - Management expects full-year 2024 cash burn to be approximately $40 million[7] Corporate Information This section covers forward-looking statement disclaimers, investor contact details, and Q1 2024 earnings conference call information Forward-Looking Statements This disclaimer warns that actual results may differ from expectations due to various risks, including product development and regulatory approvals - The press release includes forward-looking statements, and actual results may differ from expectations due to significant risks and uncertainties[11] - Factors that may cause differences include success of product development and commercialization, regulatory clearance, ability to grow, competition, market size, pricing, and ability to complete clinical studies[11] Investor Relations Provides contact information for investor inquiries, directing them to Marissa Bych at Gilmartin Group LLC - Investor contact is Marissa Bych of Gilmartin Group LLC, reachable at marissa@gilmartinir.com[12] Conference Call Details Hyperfine hosted a conference call on May 13, 2024, to discuss Q1 2024 financial results and provide a business update - A conference call was hosted on Monday, May 13, 2024, at 1:30 p.m. PT/ 4:30 p.m. ET to discuss Q1 2024 financial results and provide a business update[6] - Interested participants could register online at https://investors.hyperfine.io/, where a live and archived audio webcast was also available[6]