Latest news with #Hyperfine
Yahoo
6 days ago
- Business
- Yahoo
Hyperfine trading spiked on algorithms caching ‘AI,' says B. Riley
B. Riley analyst Yuan Zhi reiterates a Buy rating on Hyperfine (HYPR) with a $1 price target after the company's premium Swoop received FDA 510k approval weeks ahead of schedule. The new next-generation MRI system includes a new scanner and Optive artificial intelligence software, producing the highest level of image quality and uniformity, the analyst tells investors in a research note. The firm says Hyperfine kept the hardware development confidential up until yesterday, so it is likely not on many investor radars. Riley points out the trading volume of Hyperfine on Monday was greater than 100M shares, more than the entire float. This trading abnormality could be related to trading algorithms catching the keyword 'AI,' the firm contends. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on HYPR: Disclaimer & DisclosureReport an Issue Hyperfine announces FDA clearance of Swoop system Hyperfine announces FDA clearance of next-generation software Hyperfine Chairperson R. Scott Huennekens Resigns Hyperfine Holds Annual Stockholders Meeting Hyperfine Inc. Earnings Call: Transition and Growth Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
6 days ago
- Business
- Yahoo
Hyperfine Stock Rises After FDA Clears Next-Gen Swoop MRI System
Hyperfine HYPR recently announced FDA 510(k) clearance for its next-generation Swoop Portable MR Imaging system. The clearance covers an entirely new portable magnetic resonance imaging (MRI) scanner powered by Hyperfine's proprietary OptiVu AI software, delivering the company's highest level of image quality, functionality, and usability to date. The FDA clearance strengthens Hyperfine's commitment to revolutionizing bedside imaging by enabling rapid, low-field MRI capabilities without the logistical hurdles of traditional systems. With enhanced workflow, usability, and advanced AI-driven imaging, the next-gen Swoop system is positioned to bring greater clinical utility and operational efficiency to hospitals and care teams. Following the announcement, shares of the company moved 41% north and closed at $0.85 on Monday's closing. Shares of the company have lost 3.4% in the year-to-date period compared with the industry's 9.7% decline. The S&P 500 has gained 0.4% in the same time frame. This FDA clearance positions Hyperfine for long-term growth by significantly enhancing the clinical appeal and marketability of its Swoop system, enabling broader adoption across hospitals, emergency departments, and global health systems. The improved image quality, AI-driven diagnostics, and ease of use make the system more competitive against conventional MRI, potentially accelerating sales, expanding reimbursement opportunities, and opening new revenue streams. HYPR currently has a market capitalization of $46.89 billion. In the trailing four quarters, HYPR delivered an average earnings surprise of 3.1%. Image Source: Zacks Investment Research The newly FDA-cleared next-generation Swoop Portable MR Imaging system represents a major technological advancement in bedside brain imaging. The system features a newly engineered hardware platform combined with the proprietary Optive AI software. This integration delivers the highest signal-to-noise ratio to date, resulting in exceptional image quality with improved resolution, uniformity, and faster acquisition times. These enhancements are designed to meet the growing demand for high-performance imaging solutions in varied healthcare environments where traditional MRI access is limited or delayed. The upgraded Swoop system is tailored to be user- and patient-centric. It is optimized to scan a broad patient population, including pediatric, elderly, or anxious individuals, making it highly valuable in settings where patient compliance and comfort are crucial. Its compact, mobile design eliminates the need for patient transport, enabling clinicians to acquire brain scans directly at the point of care. This capability is particularly beneficial in emergency departments, ICUs, neurology offices, and even rural or under-resourced locations. The system's development was shaped through collaboration with leading institutions such as Jefferson Abington, and is actively used in the Hyperfine-sponsored NEURO PMR study. Early results from these studies report highly positive feedback from clinicians and patients alike, with notable improvements in diagnostic efficiency and patient comfort. Per a report by Precedence Research, the global portable MRI market size accounted for $4.34 billion in 2025, and is expected to be worth around $7 billion by 2034, registering a CAGR of 5.44% between 2024 and 2034. Given the market potential, HYPR is likely to witness a boost in its imaging business with the FDA-cleared Swoop system. Currently, HYPR carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader medical space that have announced quarterly results are CVS Health Corporation CVS, Integer Holdings Corporation ITGR and AngioDynamics ANGO. CVS Health, carrying a Zacks Rank of 2 (Buy), reported first-quarter 2025 adjusted earnings per share (EPS) of $2.25, beating the Zacks Consensus Estimate by 31.6%. Revenues of $94.59 billion outpaced the consensus mark by 1.8%. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. CVS Health has a long-term estimated growth rate of 11.4%. CVS's earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 18.1%. Integer Holdings reported first-quarter 2025 adjusted EPS of $1.31, beating the Zacks Consensus Estimate by 3.2%. Revenues of $437.4 million surpassed the Zacks Consensus Estimate by 1.3%. It currently sports a Zacks Rank #1. Integer Holdings has a long-term estimated growth rate of 18.4%. ITGR's earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 2.8%. AngioDynamics, currently sporting a Zacks Rank #1, reported a third-quarter fiscal 2025 adjusted EPS of 3 cents against the Zacks Consensus Estimate of a 13-cent loss. Revenues of $72 million beat the Zacks Consensus Estimate by 2%. ANGO has an estimated fiscal 2026 earnings growth rate of 27.8% compared with the S&P 500 Composite's 10.5% growth. The company surpassed earnings estimates in each of the trailing four quarters, with the average surprise being 70.9%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AngioDynamics, Inc. (ANGO) : Free Stock Analysis Report CVS Health Corporation (CVS) : Free Stock Analysis Report Integer Holdings Corporation (ITGR) : Free Stock Analysis Report Hyperfine, Inc. (HYPR) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
02-06-2025
- Business
- Business Wire
Hyperfine Announces FDA Clearance of a New Next-Generation Swoop® System Powered by Optive AI™ Software, Delivering a Transformative Leap in Image Quality
GUILFORD, Conn.--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—announced today FDA clearance of its most significant technological advancement to date. The clearance includes an entirely new portable MRI scanner powered by the proprietary Optive AI™ software. This new system delivers the highest level of image quality, functionality, and usability to date, unlocking a new brain imaging paradigm for clinicians and their patients. By combining powerful AI with a reimagined portable MRI platform, the company is redefining how—and where—brain imaging can be delivered. Share The next-generation Swoop® system incorporates learnings from five years of real-world experience across seven continents and numerous care settings. The new Swoop® system features innovations specifically engineered to deliver the highest signal-to-noise ratio, which, when paired with the Optive AI™ software, achieve exceptional image quality, including improved resolution, uniformity, and faster acquisition times. This new level of image quality has the potential to dramatically drive the adoption of the Swoop® system across multiple sites of care and clinical applications. The new Swoop® system also delivers a user and patient-centric design to accommodate a broad patient population—especially beneficial for pediatric, elderly, or anxious patients—making MRI more accessible for all. With the optimized user experience, the Swoop® system now, more than ever, empowers clinicians to acquire scans when and where it matters most. 'This next-generation hardware and the Optive AI™ software platform begin a new chapter for the adoption of AI-powered portable MRI. This clearance is the most significant innovation in the history of Hyperfine. We plan to launch the new Swoop® system across hospital and office settings in the US, and we believe the new Swoop® system performance will delight patients and providers, reduce the learning curve for users, and drive meaningfully faster adoption,' said Maria Sainz, President and CEO of Hyperfine. Collaboration with leading portable MRI programs, including Jefferson Abington, has accelerated the development of the new system. These strong clinical partnerships have helped shape hardware and software refinements critical to clinical utility. As Jennifer Villa Frabizzio, MD, Neuroradiologist at the Radiology Group of Abington, noted, 'This sleek, innovative redesign of the Swoop® system is a transformational advance for the emerging field of portable MR imaging. It improves patient comfort by accommodating a broader range of body types and increases efficiency by allowing technologists to reach patients more quickly. But the real breakthrough lies in how the hardware and software work together to deliver image quality and speed, which brings portable MRI into the realm of mainstream clinical practice." The new Swoop® system is being used in NEURO PMR, a Hyperfine-sponsored study examining the clinical utility of portable MRI in neurology offices. The two participating sites have reported very positive feedback from both users and patients so far. 'Based on my extensive experience in the NEURO PMR study, I believe the new Swoop® system marks a remarkable advancement in image quality while maintaining an affordable and compact design,' said Dr. Laszlo Mechtler, Medical Director of Dent Neurologic Institute and principal investigator of the NEURO PMR study. 'It is a compelling solution for neurology practices who want to offer on-site, cost-effective brain imaging to enhance patient care, convenience, and comfort.' With this launch, Hyperfine will turn a long-held vision to transform access to MRI globally into a clinical reality. By combining powerful AI with a reimagined portable MRI platform, the company is redefining how—and where—brain imaging can be delivered. The new Swoop® system accelerates Hyperfine's strategy to broaden adoption across a wide range of care environments, including critical care, emergency, and clinic settings in hospitals, neurology offices, and remote and rural care environments. It marks a pivotal step toward making high-quality brain imaging more accessible, efficient, and impactful wherever patients are. For more information about the Swoop® Portable MR Imaging® system, please visit About the Swoop® AI-Powered Portable MRI (V2) System The Swoop® Portable MR Imaging® (V2) System is U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. About Hyperfine, Inc. Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine, Inc. Forward-Looking Statements This press release includes 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the 'Company') may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as 'expect,' 'estimate,' 'project,' 'budget,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'may,' 'will,' 'could,' 'should,' 'believes,' 'predicts,' 'potential,' 'continue,' and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company's goals and commercial plans, the benefits of the Company's products and services, and the Company's future performance and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company's control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company's product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the impact of COVID-19 on the Company's business; the inability to maintain the listing of the Company's Class A common stock on the Nasdaq; the Company's inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company's products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company's products and services and reimbursement for medical procedures conducted using the Company's products and services; the Company's estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company's financial performance; and other risks and uncertainties indicated from time to time in Company's filings with the Securities and Exchange Commission, including those under 'Risk Factors' therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
Yahoo
14-05-2025
- Business
- Yahoo
Q1 2025 Hyperfine Inc Earnings Call
Webb Campbell; Investor Relations; Hyperfine Inc Maria Sainz; President, Chief Executive Officer, Director; Hyperfine Inc Brett Hale; Chief Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Treasurer, Company Secretary; Hyperfine Inc Frank Takkinen; Analyst; Lake Street Capital Markets Yuan Zhi; Analyst; B. Riley Securities Operator Thank you for standing by. My name is Kate, and I will be your conference operator today. At this time, I would like to welcome everyone to the Hyperfine Q1 '25 earnings call. (Operator Instructions) I would now like to turn the call over to Webb Campbell, Investor Relations. Please go ahead. Webb Campbell Thank you for joining today's call. Earlier today, Hyperfine, Inc. released financial results for the quarter ended March 31, 2025. A copy of the press release is available on the company's website as well as Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or projections of future events, results, or performance are forward-looking statements. All forward-looking statements, including, without limitation, those relating to our operating trends and future financial performance, expense management, expectations for hiring, training, and adoption, growth in our organization, market opportunity, commercial and international expansion, regulatory approvals, and product development are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our latest periodic filings with the Securities and Exchange Commission. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 13, 2025. Hyperfine disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. With that, I will turn the call over to Maria Sainz, President and Chief Executive Officer. Maria Sainz Good afternoon, and thank you for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Brett Hale. In the first quarter, we delivered revenue of $2.1 million with the sale of 6 systems, with a strong average selling price. We also reinforced our financial profile, taking steps to meaningfully reduce cash burn by completing a reorganization, and we further strengthened our balance sheet by raising $6 million through a registered direct offering to extend our cash runway to the end of 2026. In the first quarter, we experienced some headwinds to revenue associated with the new political environment, which resulted in the loss of several deals at large academic institutions that were funded by grants. The first half of 2025 marks the end of a time in our company's commercial trajectory where our business relies primarily on U.S. hospital deals. As we have previously indicated, hospitals have proven to have protracted sales cycles and high variability in deal timing. We are committed and excited about Hyperfine's future with diversified revenue across the 3 verticals of the hospital, the office setting, and international markets, and introducing our significantly improved product performance with our next-generation image quality. We still expect this catalyst to change the growth trajectory of Hyperfine starting in the second half of this year. I will now provide an update on our diversified growth catalysts coming to fruition in 2025. As we progress into the second half of 2025, our business will be a diversified portfolio with hospital, office, and international verticals providing a platform for higher growth and less variability. We have continued to make solid progress toward launch readiness for the office business. Several of the office accounts in the pilot program are now IAC-accredited, have started to scan, and are going through the reimbursement process with CMS. Neuro PMR, our office clinical study, has begun enrollment, and the 2 participating office sites are demonstrating strong enthusiasm for the Soup system. Neuro PMR is a multicenter prospective observational study comparing AI-powered portable MRI and conventional high-field MRI with respect to pathology findings, clinical utility, and patient experience in the neurology office setting to assess different use cases for the soup system. The study is being run by 2 private neurology practices, the Dent Neurologic Institute and Pepsis Neurology. The study has a target enrollment of 100 patients. Enrollment is progressing very well, and I am pleased to report that the study is about halfway enrolled, and we now expect the study to conclude ahead of our previous estimate by the end of the third quarter of 2025. Additionally, in the last couple of weeks, we have conducted training for our field teams on the office market opportunity. On the technology front, we continue to improve the image quality of our unique AI-powered portable MRI to drive broad clinical utility and mainstream adoption. We expect to obtain clearance for our next-generation software in the first half of the year and expect the commercial rollout in the second half of the year. Meanwhile, we continue to work towards the clearance and launch of another generation of soup system technology later this year. These releases will bring a step-function improvement in image quality, approaching the quality obtained from conventional 1.5 Tesla MRI systems, as noted by several key opinion leaders involved in our development process. We believe this level of image quality will make the adoption of portable brain MRI quicker for new users, enabling a shorter learning curve and accelerating market adoption of our technology. Our strategy for growth is based on site of care expansion. Our focus is on building an office business, expanding to multiple sites inside the hospital, and driving adoption in international markets. The neurology office setting is an incredibly compelling opportunity for the soup system. Neurologists directly impact 100 million patient lives in the United States. They order an average of 500 to 600 MRIs annually, and only a very small fraction of the private neurology practices staff MR imaging equipment on site. We plan to launch in the office in mid-2025. And as highlighted previously, the team has made a lot of progress towards launch readiness by initiating pilot accounts, initiating the neuro PMR study, and most recently, training the field teams. Now moving to the hospital opportunity. We have continued our expansion into the emergency department as an additional call point in the hospital, given the importance of time to scan and patient progress, and supported by the clinical work we have done in stroke. MRI availability for the triage of stroke patients in the ER is very limited, and patients and clinicians often endure long waits. Data from Action PMR shows that AI-powered portable MRI in ischemic stroke triage can help address patients quickly and provide valuable clinical insights in this highly time-sensitive environment. Action PMR evaluating the use of the Soup system for ischemic stroke patients completed enrollment at 100 patients across 4 leading institutions globally. Data was presented most recently at the 2025 International Stroke Conference. To drive expansion into DER, we plan to support additional projects to generate clinical evidence that will demonstrate the clinical workflow and economic value of the use of the Swoop system in this new site of care. Besides selling on the clinical benefits of using the Swoop system in the hospital, we have focused our team on highlighting the potential favorable economic impact of using the Swoop system. We have compiled data from key Swoop system accounts documenting incremental conventional scans enabled by the use of the Swoop system in critical care and cost savings in care associated with the use of the Swoop system, enabling faster decision-making and discharge as appropriate. This real-world data is another valuable tool our commercial teams are now using in their accounts. I am pleased to report we have seen an increase in multiple-unit deals in the hospital setting in our pipeline, illustrating the interest across several hospital call points. Finally, turning to our international commercialization activities. We continue to see strong interest and healthy demand in our markets across Europe, the Middle East, and Asia. I'm also pleased to share that we continue to anticipate regulatory approval and market entrants in India in the second half of the year. As I said on our last call, 2025 will be a tale of 2 halves, with our first half performance based on our legacy business with a heavy mix of hospital deals. The second half of 2025 will be favorably impacted by the launch of 2 new AI-powered technology releases with significant improvements in image quality, the launch of our office business and the adoption from existing and new international markets, including India, driving healthy growth and diversification of our revenue in the second half of 2025 and beyond. I remain confident in the opportunity in front of us and the execution and capabilities of our team. I will now turn over the call to Brett to review our Q1 performance and provide an update to 2025 guidance. Brett Hale Thank you, Maria. I will recap our financial results for the first quarter of 2025 before providing an update on our financial guidance. Revenue for the first quarter of 2025 was $2.1 million. In the first quarter of 2025, we sold 6 units with a strong average selling price. During the first quarter, we continued to experience longer deal timing and processes for U.S. hospitals and the loss of several deals due to significant reductions and cancellations of grant funding to academic institutions. Our average selling price and pipeline remain strong, but U.S. hospital critical care deal sales cycles continue to experience variability and are longer than in past quarters. Also, during the first quarter, a majority of our United States sales personnel were newly hired. These new members of our sales teams are gaining traction with customers while training to be prepared to build awareness and visibility of our next-generation imaging technology once cleared and launched. Gross profit for the first quarter of 2025 was $0.9 million, and gross margin for the first quarter of 2025 was 41.3%, representing a 20 basis point improvement versus the prior year period. We continue to drive healthy margins at our stage, and we believe we are well-positioned for meaningful margin expansion at scale. R&D expenses for the first quarter of 2025 were $5.0 million compared to $5.6 million in the first quarter of 2024. Sales, general, and administrative expenses for the first quarter of 2025 were $6.7 million compared to $6.4 million in the first quarter of 2024. Net loss for the first quarter of 2025 was $9.4 million, equating to a net loss of $0.12 per share as compared to a net loss of $9.8 million or a net loss of $0.14 per share for the same period of the prior year. Our net cash burn, including financing in the first quarter of 2025, was $4.6 million. As of March 31, 2025, we have $33.1 million in cash and cash equivalents on our balance sheet, inclusive of $6 million registered direct financing in February. For the first quarter of 2025, our net cash burn, excluding financing, was $10.1 million, down 16% from $12.0 million in 2024. The first quarter is typically our highest cash burn quarter during the year due to several annual one-time costs. Reducing cash burn remains a significant focus for us, and we will continue to prioritize spending discipline and optimize our operating leverage in 2025. Now turning to financial guidance, beginning with our revenue outlook. For the first half of 2025, we now expect revenue to be in the range of $5 million to $6 million. Our updated expectations for the first half revenue are a result of several U.S. deals recently lost due to cancellations of grant funding to certain academic institutions by the federal government. We believe we'll be able to more precisely forecast our second-half revenue over the coming months as our growth catalysts play out. And for the full year, we now expect revenue growth to be in the range of 10% to 20% over 2024. For the full year 2025, we are also updating our gross margin outlook to 47% to 50% for the year, representing a 280 basis point increase in gross margin on a year-over-year basis at the midpoint. We expect the progression of gross margin percentage increase to closely follow our sales growth, and we expect second-half gross margin percentages to exceed the first half. We remain optimistic that we will surpass 50% gross margins comfortably and sustainably as we realize higher volume driven by our growth catalysts. Lastly, we now expect total cash burn to be in the range of $25 million to $28 million for the full year 2025, representing a 31% decline in cash burn on a year-over-year basis at the midpoint. We have taken several steps to enhance our financial profile. We completed a restructuring in the first quarter to reduce operating costs, extend cash runway, and transition our organization from a development stage to a commercial stage company. We also bolstered our balance sheet with a $6 million financing. We will execute upon our plan with strong spending discipline while maintaining appropriate investments in our growth catalyst. We continue to see a cash runway for the business to the end of 2026. Before turning the line back to Maria, I want to briefly touch upon the topics of tariffs. We have been closely monitoring recent government commentary and actions and the potential impact on our business. Our 2025 guidance assumes that our business will not be materially impacted by tariffs. Additionally, at this time, we have sufficient inventory on hand to meet current demand. We will continue to follow the situation closely and provide updates to the market as needed. I would like to now turn the call back to Maria for closing comments. Maria Sainz Thank you, Brett. As we get closer to mid-2025, my confidence in driving a new office business, expanding in the hospital, and into more international markets, and bringing forward the highest performing image quality in the Swoop system increases significantly. The team is laser-focused on our growth drivers and very excited about the future of our company. With that, I want to thank you for your time and open up the line for questions. Operator (Operator Instructions) Frank Takkinen, Lake Street. Frank Takkinen I was hoping we could start with one on some of the pilot activities ongoing in the office setting. Most curious, I know you touched on it a little bit in your prepared remarks, but just most curious about initial feedback and whether or not this has resulted in you changing strategy, changing any timelines to go into these markets? And then I have one follow-up after that. Brett Hale Maria, do you want to take that? Maria Sainz Sorry, I was talking to myself. I was on mute. Sorry, Frank. Thank you for the question. And I was saying that we have really taken a very methodical approach to working through the pilot phase and make sure that we follow very closely the accounts from how we have pitched to them their interest in the technology to then really understanding the deal cycle, making sure that we are ready to support them and chaperone any activities associated with accreditation and then even down to implementation. So we now have the pilot accounts gone through, and all of them are now accredited by IAC. They're all scanning. And they're all going through the CMS registration and the motion. And I would say in the training meeting that we had for our sales team, we had one of those pilot neurologists come to speak to them. It is really encouraging to hear how they are thinking about this opportunity in terms of transforming their practice, being able to offer more, being able to be actually a more full-service supplier, and how easy they report feeling the technology is to operate and to bring on board. So I would say, if anything, we are feeling more bullish. I'm also incredibly encouraged by the 2 very large neurology practices that are participating in Neuro PMR. The rate at which they are enrolling patients is exceeding our expectations, which is a great testament to their enthusiasm. And also, we are seeing a variety of cases that they are willing to use in triage in patients with the Swoop system. So I am feeling that it is really the right thing for us to diversify, and there's an opportunity there that is very substantial, and we're going to be moving into that launch phase here in the next several weeks as we hit the midpoint of the year with the field team now trained. Frank Takkinen And then just for my follow-up, maybe a 2-parter. First, on the grant-funded headwind in Q1, is this an instance where if some of those grants start to come back online that, that business could be recovered? Or are you guys thinking of that as lost business at this point? And then, as a second part, just any update on initial receptivity with the international distributors would be great. Maria Sainz Sure. So I think across academic institutions, the tone of clinicians around grant funding confidence is clearly very, very sobering. So we are not expecting that they come back, even though some of the institutions actually that we were affected by were on the front page of main news streams, and they have received some of it back. There is no appetite to do anything eagerly with any grant funding because there's no confidence whether that is going to stick, stay, or get retracted. It's just a very unsettling time in that respect. Definitely, we are moving away from betting on grant funding for deals that may have had that, and we are putting all of our efforts on other deals that don't have grant funding. It is not every deal in the hospital that has grant funding as the source of funding for the acquisition of the equipment. So I don't think we expect them to come back. The question is, are we able here in the second quarter to deliver the quarter and then make anything up? Or is it going to be more challenging to find deals? As we say, most of it is hospital deals, and they have a long sales cycle. And then as it relates to international, we continue to see a lot of interest, and we are now seeing that a lot of the business internationally is very hospital-based. So we are seeing our distributors work through the pipeline. We are seeing the implementations from last year start to generate clinical activity that is encouraging. So we're starting to go deeper in some countries with our distributors. So we're looking at establishing centers of excellence. We're looking at establishing networks of users that can actually communicate and maybe not collaborate, but communicate as the pioneers on the use of swooping in different markets. And in our prepared remarks, we stated that we still feel like we will get India clearance and approval from the CDSCO, and we will do market entrants in the second half. Operator Larry Biegelsen, Wells Fargo. This is Simran on for Larry. Maybe just for guidance. If I do the math, you took the full year '25 outlook down by about $1 million at the midpoint. It does imply slightly lower second-half sales than before at the midpoint. So I guess you laid out a number of growth catalysts that you expect to come online in the second half. So maybe what's changed in your second half guidance since you set your initial guidance in mid-March? And can you talk more broadly about your expectations for the selling cycle, the hospital selling cycle, and the capital environment for the remainder of the year? Maria Sainz Brett, do you want to start? Brett Hale Yes. So I'll take that. So I think 2 things on revenue guidance. In the first half, we adjusted it to $5 million to $6 million. As Maria highlighted, predominantly, that's coming from the grant funding-related activities that we do not anticipate necessarily coming back. So the first half, we adjusted, and then we also adjusted the full year guidance, which also incorporates some of that grant funding-related revenue that we do not anticipate that we'll be capturing here for fiscal year '25. So, no major changes in terms of our anticipation for second half guidance, how we think about the prospects of the business, and the growth drivers will all be in place. But given what we saw in Q1 in terms of grant funding, we made adjustments to both the first half as well as the full year guidance. Maria Sainz And I think you had a question regarding the capital cycle. I think that's what I don't know, that we are seeing anything different than what we have been messaging for the last several quarters, which is that they are definitely getting longer. I think about 1.5 years ago or so, I was estimating our hospital deals were going to take us about 9 months or so. I would say, often now, they are a year or 1.5 years in some instances. So we have a really robust pipeline of hospital deals, but they are going to take their time to happen. And I would say it's probably in that year to 1.5 years time frame now, as we think about where that stands. And maybe just a follow-up on the in-office expansion. Have you talked about how many office sites of care are in the launch readiness phase? And can you elaborate on the economics of selling in the office versus the hospital setting in light of today's macro environment? I know on the previous call, you talked about flexible payment models here. Maria Sainz Yes. So we haven't mentioned how many accounts are in the pilot phase. I would say it's fair to say it's like a handful. And those are the ones that have gone through the motions definitely in the last several weeks, the accreditation, the starting to scan, and then the beginning of the process around reimbursement and CMS registration. Again, we have now gone through the drill of implementation. I would say, as simple as implementation, shipping a device and training on the device is a very, very different experience in the hospital than in the office. In the hospital, the moment we get a PO, usually, we ship the device, and the hospital has no problem storing a device and implementing it when their teams are already there, and all the connectivity has happened, and lots of those things. With the office, they really pick a date. And at that date, everything needs to happen. You need to open the crate, you need to put the device into motion, you need to train the team, and it's sort of one and done. And sometimes we need to do it after hours or over the weekend because that is the plan that they have available. So again, it's been a handful of accounts with whom we've actually learned the whole drill from pitching a deal all the way to implementing and the different steps. In terms of pricing, I think we are continuing to talk about flexibility to accommodate. They definitely have an appetite to pay overtime rather than all at once. It depends on the size of the account. I think we are doing an economic model to understand whether they are really ready for our device. A lot of it depends on the number of cases that they refer to. We talked about the fact that they do 500 on average, a neurology office refers about 500 to 600 patients a year for an MRI. So that definitely it falls right in when this makes sense at our price point. But we are seeing variability in the way we're potentially going to transact with the offices based on their size and their appetite to pay more upfront or pay more over time. Brett, feel free to add any other commentary here. Brett Hale No, I think that's fair. I mean, there are over 2,000 neurology offices, and there obviously is a segmentation within that size. So there are some that are more sole proprietary that have a look and feel of what their business looks like, versus those that are more than 5 to 10 practitioners within a setting. So each one of those has a little bit different dynamics. I would say health economics has been something that's been front and center, both in the office setting as well as what we're bringing to the hospital setting. So each one of those has a very compelling use case. We do allow for some degree of making sure that we can meet the practice where it makes sense for their business model. Operator Yuan Zhi, B. Riley Securities. Yuan Zhi Maria, maybe on the tariff because to tariffs, can you clarify if some of your international orders are delayed to a later time, or were they just canceled? Brett Hale Yes. So, I mean to date, we haven't had any impact of any tariff-related delays of any of our transactions with our third-party distributors to date. So that hasn't come to fruition. We're in the early stages, as you know, of international market development. But to date, no direct tariff impact. Yuan Zhi Maybe a follow-up question there. So, for the 1Q 2025 product revenue, most of the products from the U.S. market, with a very minor contribution from international? And any reason why? Brett Hale So there's been a -- any individual quarter, there's been variability, as you know, in terms of our mix. So I guess, for the first quarter of 2025, I guess I would highlight that we sold 6 units. The effective ASP was $254,000, which was actually a very strong ASP. But any individual quarter, we can have variability in terms of what the demand is and what the sales are. So nothing specific to comment about the mix per se in Q1. Yuan Zhi And maybe one last question from us. So now we are in May, what is your current visibility for the first half of 2025, and then for the full year 2025? The other way to think about this is which bucket of orders you think is at risk, and which bucket of orders you think you have higher confidence in? Maria Sainz I think as we think about I mean, as we think about the second half of this year, that's when we get into this more balanced portfolio of opportunities. And we have the hospital, we have international, we add to international India, and we have the office. So we are managing the pipeline across all of those buckets to have higher confidence as to how things are going to play out based on different sales cycles and time frames. So as I said, the pipeline is very robust. We have also now had a little more run time with the new team, which, as we said, was close to 50% of an upgrade at the beginning of the year, and we are very impressed by the pipelines that they are driving as well as new individuals as well as the legacy team. So I would say the pipeline looks very robust, and we're starting to build the pipeline for the office for the second half. Most of what is going to be driving the business in this second quarter, to round up the first half, is going to be the hospital. That's why there is definitely a significant ramp in total business between the 2 halves, the first and the second. Operator (Operator Instructions) I will turn the call back over to Maria for closing remarks. Maria Sainz Well, thank you very much for attending today's call and for your questions, and we look forward to updating you at the end of the second quarter. Take good care. Operator Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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13-05-2025
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Hyperfine, Inc. (HYPR) Reports Q1 Loss, Lags Revenue Estimates
Hyperfine, Inc. (HYPR) came out with a quarterly loss of $0.12 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.14 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this company would post a loss of $0.16 per share when it actually produced a loss of $0.14, delivering a surprise of 12.50%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Hyperfine , which belongs to the Zacks Medical - Instruments industry, posted revenues of $2.14 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 27.07%. This compares to year-ago revenues of $3.3 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Hyperfine shares have lost about 17.1% since the beginning of the year versus the S&P 500's decline of -0.6%. While Hyperfine has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Hyperfine: favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.11 on $3.09 million in revenues for the coming quarter and -$0.45 on $15.59 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Instruments is currently in the top 31% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Zomedica Corp. (ZOMDF), has yet to report results for the quarter ended March 2025. The results are expected to be released on May 15. This company is expected to post quarterly loss of $0.01 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Zomedica Corp.'s revenues are expected to be $7.78 million, up 24.3% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Hyperfine, Inc. (HYPR) : Free Stock Analysis Report Zomedica Corp. (ZOMDF) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
