Hyperfine, Inc.

ladies and gentlemen thank you for standing by and welcome to the hyperfine q2 2022 earnings call at this time all participants are on a listen-only mode after the speaker's presentation there will be a question and answer session to ask a question during the session lead to press star one one i would like to turn the call over to your host mr sebastian maybe again thank you for joining today's call earlier today hyperfine released financial results for the fiscal quarter ended june 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, position training and adoption, growth in our organization, market opportunities, 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 factors section of our 10Q filed with the SEC on May 12, 2022. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 10, 2022. HyperSign declares 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, thank you again. I will turn the call over to Scott Honeckens, Interim President and Chief Executive Officer of Hyperfine.

Thank you, Marissa. Good afternoon, and thank you all for joining us. I'm also joined by our Chief Financial Officer, Alok Gupta. We are pleased to continue the conversation on Hyperfine's story with you today and highlight our recent progress. But first, I would like to reacquaint listeners with our vision as a company and our transformative solution in the field of medical imaging. Hyperfine's vision is to transform the healthcare by creating access to lifesaving diagnostics and actionable data at the patient bedside. Today, brain diagnostics are a single point in time and delay the time from door to discharge. Our mission remains to transform that experience, first and foremost, with our portable bedside MRI system. Our initial product, our portable MRI system called Swoop, was FDA cleared in 2020. Today, we are driving adoption of the Swoop system in the hospital setting to solve significant unmet patient and provider needs. This device addresses an immense $20 billion-plus medical imaging market opportunity, considering the potential for installations across hospitals, clinics, outpatient centers over time. Today, just 10% of the world's population has access to MRI, and we are committed to improving that. As we have noted in the past, our near-term opportunities for improving patient care are, first, in the ICU, secondly, in pediatric hospitals to address hydrocephalus, and third, in 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 it takes time to get imaging completed and can be prohibitively long in the process and consume valuable resources. There's simply not an effective way to perform MRI imaging for ICU patients today. We've been working with our clinical partners to build strong clinical validation to support the ICU use case. Turning to hydrocephalus, a disease that accounts for over 40,000 hospital admissions each year and is an excellent use case for portable MRI. Hydrocephalus is characterized by a buildup of fluid in the brain addressed by introducing a shunt and tubing to drain that fluid. Although MRI is the preferred approach for regular imaging of these patients, patients are typically taken for CT scans due to lack of MRI availability. Our technology enables a quick, simple, radiation-free diagnosis process for shot failure. This July at the National Hydrocephalus Association Conference, HA Connect, we announced a new software enhancement that enables brain scans for hydrocephalus patients in under three minutes with no ionizing radiation. This development is especially significant for younger patients who may have difficulty staying still without sedation and have previously received a CT scan. HyperFi is an official partner with the Hydrocephalus Association, the nation's most widely respected organization dedicated to research and advocacy of hydrocephalus. These are just two examples of use cases where we have received overwhelmingly and early positive responses to the SWOOP system. We have systems located at leading institutions across the country with ongoing studies to add even greater validation to the utility and clinical efficacy of our technology in both of these use cases. 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 and we are continuing to leverage research, including the independent publication by our partners at Yale and Harvard Massachusetts General in Science Advances earlier this year to build awareness of the value of SWOO in the detection and evaluation of stroke. As a reminder, this Science Advances paper concluded that hyperfine SWOO enables highly accessible and dynamic bedside evaluation of ischemic stroke. obtaining actionable bedside neuroimaging for 50 confirmed patients. Overall, SWOOP detected infarcts in 45 of 50 patients, or 90%, and captured lesions as small as 4 millimeters. 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 MRI to obtain clinically useful imaging of stroke, setting the stage for broader use. We're continuing to engage multiple US hospitals to collect data demonstrating the clinical value of SWOOP in stroke patients. As we gather greater clinical data, we will increase our focus on driving awareness and educating the field about SWOOP utilization for the stroke use case. We look forward to sharing our progress over the coming quarters. In addition to improving patient workflow and saving critical time for these use cases across ICU, hydrocephalus, and stroke patients, we remain hard at work on our next generation development to expand use cases beyond the intensive care unit and hydrocephalus into stroke and new anatomy such as C-spine. I would like to highlight a recent strategic initiative. We've had the exciting opportunity to launch a partnership with Viz.ai, a leading AI-powered disease detection and intelligent care coordination platform to bring MRI to the patient's bedside and deliver valuable insights to the clinician's fingertips for timely decision making. The partnership between Hyperfine and Viz.ai further validates our aligned mission statements to provide fast and accurate point of care Through intelligent software, together we are opening doors to expedite clinical access to MRI imaging and increasing access to time-critical diagnostics in acute and post-acute care phase. With Viz AI, we are hoping to introduce SWOOP to new sites of care as we continue generating awareness of our value proposition. Now, turning to our recent commercial progress, we installed nine commercial swoop systems in the second quarter of 2022, driving revenue of $1.53 million. Our progress included broadening our global footprint to Australia and New Zealand, where we placed commercial units and established the foundation for additional installations over time. We are pleased that we have continued to develop and enhance our customer relationships, working closely with neurosurgeons, interventional neuroradiologists, and critical care clinicians alongside radiology and hospital executives, all influential stakeholders to roll out successful new programs and placements. However, our business has not been immune to the challenges of today's selling environment. These include limitations to accessing hospital administrative personnel and department leadership, staffing shortages at hospitals, local regulatory and administrative approval timing of new purchases, and spending constraints in today's inflationary environment, all resulting in an overall elongated sales cycle. These factors have detracted from our ability to finalize contracts in the timing we had projected. As the macro environment continues to impact order timing, we are also projecting an elongated sales cycle going forward. As a result, we are revising our 2022 expectations to 35 to 45 commercial system installations and 7 to 8 million in total revenue. Despite our lower near-term expectations, we remain highly confident in our value proposition and long-term goals. Our team remains hard at work stimulating awareness of our technology, and we have a robust network of ongoing communications with existing and new potential customers that leave us optimistic for the future. We continue to expand our commercial footprint and are not losing opportunities in our pipeline. the time to close sales is simply proving longer than we projected at the start of the year. For example, just this week we received a signed letter of intent for seven commercial units from Barnes-Jewish Healthcare System in St. Louis, which is one of the leading hospital systems in the United States. We expect to receive a final purchase order from BJC Healthcare within the quarter, and we anticipate delivering these systems over the next six months. We originally expected this order in June, a testament to the slower selling process or approval process we are experiencing today. Separately, I'm pleased to announce that we've received a letter of intent from King's College London to order 20 commercial systems. This is in association with the Bill and Melinda Gates Foundation. We expect to receive a final order shortly and begin shipment of these units over the next several months. Lastly, given market conditions and the elongated sales cycle, we have updated our intermediate term operational plan with a focus on prioritizing projects and extending our cash runway. We feel good about the momentum we are building for sales growth in 2023, and 2024, and we are continuing to prioritize our commercialization, clinical and R&D spending accordingly. We are confident that we have adequate capitalization given this plan through year-end 2024. We will continue to be diligent in our OpEx planning while continuing to invest where we see potential for the greatest growth. As part of the prioritization of all projects and expenditures, we will be assessing the company's 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 towards achieving our long-term goals. Before I turn the call over to Alok, our Chief Financial Officer, a quick note on our CEO search. We are working with a leading global search firm and are in the process of interviewing multiple high-level seasoned executives for our CEO role. We are excited about the quality and depth of candidates for the position and are hopeful to have the role filled in Q4. I will now turn the call over to Alok to review our second quarter performance and financial outlook in greater detail. Alok?