Hyperfine, Inc.

Good afternoon, and welcome to HyperFind's third quarter 2022 earnings conference call. At this time, all participants are in listen-only mode. We'll be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Marissa Beisch, Investor Relations, for a few introductory comments.

Thank you for joining today's call. Earlier today, Hyperfine released financial results for the fiscal quarter ended September 30, 2022. A copy of the press release is available on the company's website, as well as sec.gov. 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 provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions 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, physician training and adoption, growth in our organization, market opportunity, commercial and international expansion, regulatory approvals, and product development are based upon our 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 factor section of our 10-Q filed with the Securities and Exchange Commission on August 11, 2022. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 10, 2022. HyperFind claims 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. And with that, I will turn the call over to Maria Sainz, President and Chief Executive Officer.

Good afternoon, and thank you all for joining us. I am honored to lead today's call as the new president and chief executive officer of Hydrofine. On the call with me is our chief financial officer, Alok Gupta, and our executive chairman, Scott Hankins. I will start my remarks by sharing the good news. We placed 10 subsystems in the third quarter, driving all-time quarterly revenue of $2.3 million, and we drove great discipline in spending. Successes which I credit to Scott, who stepped in as interim CEO shortly after Dave's departure and has enabled a very smooth transition in my first two weeks in the role, and to our broader Hyperfine team. We will discuss these quarterly results in greater detail shortly. Before we do that, I would like to briefly share the reasons that compelled me to take this position with Hyperfine and lead the company into our next phase of growth. I have spent the better part of the last 30 years introducing disruptive and pioneering technologies to address large markets with significant unmet patient needs, from the early days of metal stents and thrombectomy devices to cardiac resynchronization therapy for heart failure. And I am no stranger to Hyperfine having served on the board of directors since late 2021. I believe our addressable market is very large, and our initial clinical use focus in neurocritical care and stroke are very substantial global opportunities. I am confident our business is poised for expanding adoption with the right team in place and a strong foundation of independent clinical research, as well as a growing base of positive provider and patient experiences and testimonials with a soup system. Our vision is to transform healthcare by accelerating and broadening access to clinically valuable diagnostics and actionable data at the patient's bedside. Today, brain diagnostics are costly, oftentimes not readily available, and require planning and scheduling. Our mission is to expand imaging and diagnostic capacity with our soup portable bedside MRI system by providing a point of care tool, especially in critical care situations, circumstances in which magnetic resonance is superior to non-contrast computed tomography or CT scanning, and in environments where patients do not have access to imaging. Although it remains early in our course of our commercial trajectory, I am confident we are taking the right step to do so. As we have noted in the past, we see our greatest near-term opportunity to improve patient care in neurocritical care followed by stroke. Patients in the ICU for neurological conditions experience a variety of challenges when it comes to getting an MRI. Patients are typically too unstable to transport to the MRI suite for imaging And the time it takes to get the imaging completed can be prohibitively long, and the process can consume valuable resources, especially in the current staff-constrained healthcare environment. There's simply not an effective way to perform MRI imaging for neuro-ICU patients today. We have been working with our clinical partners to build strong clinical validation to support the neuro-ICU use case. We also remain focused on building our base of clinical data in stroke. Data demonstrates that MRI scans can better detect ischemic stroke damage compared to CT scans. And we are continuing to leverage research to build awareness of the value of soup in the detection and evaluation of this devastating event in patients' lives. This base of research includes the independent publication by our partners at Yale and Harvard Mass General in Science Advances earlier this year, which concluded that SOOP enabled highly accessible and dynamic bedside evaluation of ischemic stroke by obtaining actionable bedside neuroimaging in 50 confirmed patients. The authors highlighted the safety and convenience of portable low-field MRI as a tool to expedite the stroke treatment pathway and concluded that results validated the use of low-field portable MRI to obtain clinically useful imaging of stroke, setting the stage for broader use. We are continuing to engage multiple US hospitals to collect data demonstrating the clinical value of soup in stroke patients. As we gather greater clinical data, we will increase our focus on driving awareness and educating the field about soup utilization for the stroke use case. We are excited to share that we will soon be commencing a stroke study in three leading US institutions, and we look forward to sharing our progress over coming quarters. In addition to these efforts, we are advancing important technology initiatives, including refining our software programs and enhancing our AI capabilities to optimize our sequences for our use cases. Our R&D team has been hard at work toward improvements already, and we expect this to remain an area of focus into the year ahead. Turning to a recent commercial progress, as I've mentioned earlier, we installed 10 commercial subsystems in the third quarter of 2022, driving record quarterly revenue of $2.3 million. We are pleased that we have continued to develop and enhance our customer relationships, working closely with critical care clinicians interventional neuroradiologists, and neurosurgeons, alongside radiology and hospital executives, all influential stakeholders to roll out successful new programs and placements. It is worth mentioning that the introduction of SOOC creates an initial change in workload and protocols for our customers, something that takes time and effort across stakeholders. We're entering 2023 with a clear roadmap of technology iterations and enhancements from the experience of our initial users, as well as ways to optimize our go-to-market strategy. Our team is aligned and ready to execute, and we will continue to learn from our market experience and further refine our plans to improve our execution and drive continued success. To this end, we remain focused on our initial clinical use cases And as we grow and expand, we also learn. We are committed to being very responsive to market feedback to drive adoption and use of soup across multiple applications and clinical settings. Although the time to close sales has proven longer in the current operating environment, we continue to expand our commercial footprint and cultivate opportunities in our pipeline for quarters ahead. For example, in August, we announced that we had received a signed letter of intent for seven commercial units from BJC Healthcare in St. Louis, one of the leading hospital systems in the US. We are pleased to share that we have now begun delivering this system. We also share that we have received a letter of intent from King's College London to order 20 commercial systems in association with the Bill and Melinda Gates Foundation. We have now received the final purchase order for these 20 systems and expect to begin shipping some of these units over upcoming months. Before I turn the call over to Alok, I would like to reiterate our stance from recent months, which has been that given market conditions and the elongated sales cycle, we are focused on investing in our business thoughtfully, with a focus on driving near-term and intermediate-term growth, while extending our cash runway. We feel good about the momentum we're building for sales growth in 2023 and 24, and we're continuing to prioritize our R&D, clinical, and commercialization spending in that order. We will be diligent in our OPEX planning while investing where we see potential for the greatest growth. And as part of the prioritization of all projects and expenditures, as we have previously communicated, we are actively assessing strategic options for Liminal, our brain-sensing platform, which is in the early stages of development, with a view towards maximizing shareholder value creation across all of HyperFi. In summary, we are pleased with our progress toward achieving our long-term goals. I will now turn the call over to Alok to review our third quarter performance and financial outlook in greater detail.