Hyperfine Q2 2024 Earnings Call Transcript

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Provided by Quartr
August 8, 2024

There are 5 speakers on the call.

Operator

Good afternoon, and welcome to Hyperfine's Second Quarter 24 Earnings Conference Call. Currently, all participants are in listen only mode. We will 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 Marisa Beige from Gilmartin Group for introductory disclosures.

Speaker 1

Thank you for joining today's call. Earlier today, Piper Fine, Inc. Released financial results for the quarter ended June 30, 2024. A copy of the press release is available on the

Speaker 2

company's website as well as

Speaker 1

sec.gov. Before we begin, I'd like to remind you that management may make statements during this call 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, 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.

Speaker 1

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 filing with the Securities and Exchange Commission. This conference call contains time sensitive information and is accurate only as of the live broadcast today, August 8, 2024. Hyperfine, Inc. 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.

Speaker 1

And with that, I will turn the call over to Maria Saines, President and Chief Executive Officer of Hyperfine.

Speaker 2

Good afternoon and thank you for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Fred Hale. Our strong performance in 2024 continued in Q2 with a record quarter at $3,600,000 in total revenue and a balanced mix of U. S. And international deals.

Speaker 2

In the U. S, we continued adding flagship accounts to our ranks of early and enthusiastic users and the pipeline is growing strong. International contributions to revenue were also very healthy in Q2. We are pleased with the engagement and performance of our distribution network. I would like to share that we conducted our first in person service and product training session for our global partners early in the quarter.

Speaker 2

Beyond our strong commercial traction, we achieved several important milestones associated with our innovation and clinical programs. The recently announced clearance by the FDA of our 9th generation AI powered software marks a critical step forward in the imaging capability of our unique ultra low field portable brain MRI. We are now able to upgrade the image quality and reduce acquisition time, delivering higher overall clinical performance. Reducing scan times may help speed up the diagnostic process in certain clinical circumstances like acute care settings, which can be crucial for time sensitive medical conditions such as stroke, where time is brain. Artificial intelligence remains a powerful engine behind our sequence development innovation.

Speaker 2

And it has been very rewarding to see how our total number of AI powered marketing authorizations places our company in a leading position on the FDA's list of artificial intelligence and machine learning enabled medical devices recently published. On the clinical front, enrollment began in the CARE PMR study in oral Alzheimer's program and it has been progressing well. We are now scanning for the detection of ARIA complications in patients who are taking amyloid targeting therapies at 3 Lekemd infusion program and are in discussions with several other potential study sites. As a reminder, Care PMR compares portable ultra low field brain MRI with a high field commercial MRI to assess the ability of SUK system to detect ARIA complications in patients taking amyloid targeting therapies. And just last week at the Alzheimer's Association International Conference, Washington University and Matt General Brigham presented very promising initial data on ARIA detection with soup as well as the use of soup for monitoring the progression of Alzheimer's.

Speaker 2

The first poster was presented by Doctor. Oka For from Washington University and included the images of 1 of the first ARIA cases observed in the study on both a conventional 3 Tesla scanner and the Supe Ultra Low Field Portable Scan. The 2nd poster presented by Doctor. Taylor Kimberly from Mass General Brigham focused on the quantitative assessment of ultra low field MRI images compared to conventional high field MR images in evaluating brain morphometry in Alzheimer's patients and highlighted a strong agreement in volumes between conventional MR images and SOUP images. The authors concluded, Given its portability and low operational cost, low field MRI holds promise as a valuable tool to diagnose Alzheimer's disease and monitor its progression.

Speaker 2

There are real workflow benefits to bringing brain imaging closer to patients with Alzheimer's disease, their clinicians and care partners with the potential to have substantial impact in access, cost and equity in Alzheimer's care. We expect to significantly optimize workflow and ultimately open up the opportunity for more patients be monitored and treated safely and efficiently at different sites of care. In stroke, Action CMR is progressing well. This is a multi center evaluation assessing the use of the tube system for the triage of acute steaming stroke. The initial 100 patients have been enrolled to evaluate acute stroke detection with a subsystem as compared to CT and conventional MRI.

Speaker 2

Recently, we announced the publication of our subset of data from the study providing early evidence that the Zoop system is a promising tool for enabling critical stroke treatment choices in urgent care settings. The data is published in the August 2024 edition of Annals of Neurology and highlights ocellophila MRI's ability to be used as a tissue clock to characterize acute stroke. We look forward to having additional data shared later this year. We also plan to launch the workflow phase of our study to assess the efficiency and economic value of accessible brain MRI in disease and spoke settings to triage stroke. Now building on the momentum we have across all of our initiatives, I want to provide more detail on the acceleration we expect to see in our business as early as 2025.

Speaker 2

We have also detailed this catalyst on Slide 12 of our most recent investor presentation deck, which can find on our Investor Relations website. As the field of Alzheimer's care continues to rapidly evolve, we are generating data to support the clinical utility and workflow benefits of the TOUK system for this patient population. We anticipate that we will be placing Sook systems in neurology clinics, infusion centers and other Alzheimer's care programs commercially in the second half of twenty twenty five. The stroke opportunity will open up the placement of 2 units in EDs and hub and spoke stroke networks. Cell 3 ash is creating significant challenges in EDs across the U.

Speaker 2

S, resulting in considerable clinical and economic burden. The EASA subsystem can provide a readily available MRI tool to triage stroke, EDs and stroke sites, positively impacting stroke care and costs. We anticipate ED placements to be incremental to critical care placements in the hospital setting and we expect revenue contribution from this opportunity starting in the second half of twenty twenty five. We have also been pursuing opportunities outside of the hospital. I would like to now provide detail on our entrance into the neurology office setting as a new and additional business for subsystem placement.

Speaker 2

Our initial step in our plan to enter neurology offices is obtaining accreditation and we are pursuing expanded out of hospital and clinic setting accreditation through the Inter Society of Accreditation Commission, IAC, which we anticipate being completed by the end of this year. Additionally, the American College of Radiology of low field point of care MRI. We are pleased that major accreditation bodies are now formally acknowledging the importance and emergence of low field point of care MRI. We are mobilizing resources to support this new opportunity for hyperfine. And we expect to see revenue contributions from the new office business also in the second half of twenty twenty five.

Speaker 2

Furthermore, international expansion will be another growth driver in 2025 as we will have a full year of our international distribution network in place as well as a potential regulatory approval in India in the second half of the year. Clinical use internationally is similar to what we have seen and trying to do in the U. S. And we anticipate subsystem placement in international markets across multiple types of care, including adult and pediatric care settings. The diverse soup system adoption expansion and growth opportunities ahead of us are all large and compelling.

Speaker 2

The fundamentals of our business are solid. Based on our proprietary technology, our leadership position, our track record of innovation, our healthy gross margin profile and strong spending discipline. We have multiple, large and near term opportunities to grow from a strong foundation, and I am confident we will see significant business acceleration in 2025 and beyond. I would now like to turn the call over to Brett to review our performance in the quarter.

Speaker 3

Thank you, Maria. Turning to our financial results for the Q2 of 2024. Revenue for the quarter ended June 30, 2024 was $3,600,000 up 7% compared to the Q2 of 2023 and up 10% compared to the Q1 of 2024. Gross profit for the Q2 of 2024 was $1,800,000 compared to $1,400,000 in the Q2 of 2023, resulting in a record gross margin of 50%. R and D expenses for the Q2 of 2024 were $5,900,000 compared to $5,300,000 in the Q2 of 2023.

Speaker 3

Sales, general and administrative expenses for the Q2 of 2024 were $6,700,000 compared to $7,800,000 in the Q2 of 2023. As outlined by Maria, we continue to invest in the areas of innovation and operate lean. Net loss for the Q2 of 2024 was $10,100,000 equating to a net loss of $0.14 per share as compared to a net loss of $10,600,000 or a net loss of $0.15 per share for the same period of the prior year. The improvement in net loss was a result of our strong revenue, expanding gross margin and continued spending discipline and cost saving initiatives implemented across the business over the past year. Our cash burn in the Q2 of 2024 was 9 point $4,000,000 and as of June 30, 2024, we had $53,800,000 in cash and cash equivalents on our balance sheet.

Speaker 3

Turning to guidance. We are raising our revenue outlook for the full year 2024 to a range of $13,000,000 to 16,000,000 dollars We expect continued commercial progress in the second half of the year with the expectation of some summer seasonality impacts given our increased mix of international revenue. We are driving healthy margins even at small scale and we were pleased to drive a record 50% gross margin in the Q2 of 2024. We have a differentiated and attractive profile among medical imaging companies and companies at our scale, and we are optimistic that we will surpass 50% gross margins comfortably and sustainably over time as we realize the commercial acceleration from our growth catalyst. For the full year 2024, we continue to expect gross margins to be in the range of 45% to 50%.

Speaker 3

We continue to anticipate total cash burn of approximately 40,000,000 for the full year 2024. We expect our cash burn to be below 2023 levels and we will execute this plan while sustaining investments in our key growth drivers. We also continue to see a cash runway for the business into early 2026, funding the commercial realization of the growth catalyst Maria mentioned previously. At this point, I'd like to turn the call back to Maria for closing comments.

Speaker 2

Thank you, Brett. I'm proud of the strong progress that Hyperfine team made in the Q2 year to date, both advancing our growth initiatives and delivering record revenue. I remain very optimistic in our ability to execute and deliver significant business acceleration in 2025 and beyond. Just last week, I was able to witness firsthand the interest and enthusiasm for what portable MRI can represent in Alzheimer's care. The Alzheimer's disease field is an area of huge unmet need with significant investment from the pharma industry, global policymakers and advocacy groups.

Speaker 2

It is rapidly evolving and the focus on access, equity and workflow simplification is often in the center of the debate, which reinforces how we assess the fit and the potential for the soup system. With that, I want to thank you for your time and open up the line for questions.

Operator

Thank you. The floor is now open for questions. Your first question comes from the line of Yuan Jie from B. Riley. Please go ahead.

Speaker 4

Maria, congrats on a very good quarter and thank you for taking our questions. I got a couple of questions here. First, we'd love to hear the reasons for you to update the international sales? And then if you can comment on your confidence reaching the guidance here, that would be great. Then I have another follow-up.

Speaker 2

Sure. Thank you, Yuan. So clearly, the first half has been a strong first half, and we're closing the first half with a strong momentum across both our U. S. And our international channels.

Speaker 2

And that has gotten us to really raise the guidance with confidence that we can deliver a little bit more than we thought before in light of how well the international channel has responded with our support, but also the strength of the pipeline in the U. S, both in adult and pediatric hospitals, which we have been mentioning for the last few quarters.

Speaker 4

Got it. Got it. So for it was great to see the poster presentation at AIC and I have heard positive feedback on the product demonstration. I'm just curious, have you thought about the timeline to convert some of the leads from AAIC into others?

Speaker 2

Great question. And yes, we were very, very pleased with the reception at AAIC of our technology, the image quality, the patient experience. We had over 300 of the participants who volunteered and waited in line to get scanned with our device to experience firsthand what that would represent to their patients. And we had many of them also checking with Doctor. Knop, our medical officer in our viewing station and look at the images and the quality of the images.

Speaker 2

It is a little early to know how quickly a lot of this interest will funnel into orders, but we definitely came home with a long list of follow-up items across a lot of interesting opportunities. Definitely, we uncovered some of the larger Lechem B programs that are out there that would be great targets for us to continue to collect ARIA data. There was interest from some of the other industry players that we're following up on. There was renewed and continued interest from some of the ADRCs we had already contacted that are willing to go a little bit faster and getting involved with our technology. There was also interest around doing community based screening using our device to keep filling the funnel of potential likely candidates for the ATT drug therapy.

Speaker 2

So we are anticipating and we've chosen to add a slide to our investor deck that really the entry commercially into Alzheimer's is really right around the second half of next year. So we are really seeing it as a growth as a revenue contributor starting about that timeframe.

Speaker 4

Got it. One last question before I jump back to the queue. I'm curious any update we should be watch at the C TAP clinical trial in Alzheimer disease conference in Madrid at the end of October?

Speaker 2

Yes, great question. And of course, that is our next very important Alzheimer's meeting. That is the CTAD, so clinical trials in Alzheimer's disease, which as we said is end of October in Madrid. We will have additional data presented from side by side, really the same case on a 3T side by side really the same case on a 3P technology, which is the encouraging sort of token that starts pointing to the merit of our technology in detecting ARIA. So expect to see more data presented by Doctor.

Speaker 2

Ocofor again in Madrid late October.

Speaker 4

Got it. Great. Thanks for taking our questions and again, congrats on a good quarter.

Speaker 2

Excellent. Thank you very much. There are

Operator

no more questions at this time. That concludes our Q and A session. I will now turn the call back over to Maria Sainz for closing remarks. Please go ahead.

Speaker 2

Thanks to all for joining us here today. We look forward to further updates from Hyperfine next quarter.

Operator

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

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