Hyperfine, Inc. Q1 FY2023 Earnings Call

At this time all participants are in listen-only mode. After the speakers presentation there will be a question-and-answer session. Please be advised that today’s conference is being recorded. It is now my pleasure to introduce Marissa Bych from Investor Relations.

Great! Thank you for joining today’s call. Earlier today Hyperfine Inc. released financial results for the quarter ended March 31, 2023. 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 includes 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. 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, May 11, 2023. 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. 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. On the call with me is our Chief Administrative Officer and Chief Financial Officer, Brett Hale. We achieved measurable growth in the first quarter of 2023, with an all time record revenue of 2.6 million driven by the sale of 10 commercial Swoop systems. In addition, we have continued to execute with a financial discipline that allows our cash runway to extend through the end of 2025. I am pleased with our progress this quarter, and I am confident that we are poised to execute our plan in 2023. As we mentioned in March, we are focused on three strategic pillars; innovation, clinical evidence and commercial expansion with a strong focus in the US. On innovation, we continue to lead and advance ultra-low MRI with technology iterations and enhancements that further improve image quality as well as the provider and patient experience with Swoop. In February, we announced the receipt of two FDA 510(k) clearances for Viz.ai powered software updates to the Swoop system. The latest Viz.ai powered software has now been installed in the units in the field. And the feedback from existing users has been very positive, especially on the diffusion weighted imaging or DWI sequence. Our commercial team is now using images in cases with our latest software in their discussions and demos with prospective accounts and feedback has been very positive from prospective users as well. Despite our heightened OpEx discipline, we remain committed to investing in innovation and evidence and we have allocated a healthy budget to R&D through the next several years. We have active development programs working on next generation hardware, additional upgrades to software and Viz.ai for our current critical care application and future stroke pediatrics and neurodegenerative disease use cases. Furthermore, our partnership with the Bill & Melinda Gates Foundation provides access to a network of leading experts in the field of MRI across the globe, who work in a collaborative manner with our development and clinical science team. On tangible evidence, we are pleased to see abstract papers and symposia focusing on ultra-low-field MRI and the use of our Swoop system at major scientific conferences. For instance, at the International Stroke Conference (ISC) and the American Society of Neuroradiology (ASNR). At ISC in February, we were pleased to see new clinical research data from Yale, showing the potential for Swoop to provide critical brain imaging following thrombectomy in stroke patients. At ASNR in Chicago last week, we had an interactive case review session with a panel of six leading neuro radiologists, evaluating patients based on Swoop images with our latest software. This interactive session brought nearly 300 attendees and there was strong booth traffic at the conference. We also have strong research partnerships with leading institutions working on other applications of the Swoop system in adult and pediatric brain imaging. Our major clinical initiative in 2023 is the Action PMR project. Action PMR is a global multicenter evaluation that will assess the use of the Swoop system in the acute ischemic stroke use case and we're fortunate to be working with prominent, experienced and passionate clinical teams in the field of stroke. As a reminder, this is an exciting project for us as it represents the first step in pursuing the use of Swoop in acute stroke imaging. We look forward to beginning Action PMR enrollment midyear, and sharing our progress on upcoming calls. Turning to commercial expense. We're pleased with the pipeline of deals driven by our commercial team for 2023 and beyond. The commercial team has also begun implementing our higher pricing and we are encouraged by the solid momentum across multiple territories in the U.S. As we shared in the fall of 2022, we received a purchase order from King's College London for 20 commercial systems in association with the Bill & Melinda Gates Foundation and a signed letter of intent for seven commercial units from BJC Healthcare in St. Louis, one of the leading hospital systems in the U.S. to continue to execute the delivery of commercial systems in 2023. We're very pleased with our new leadership and commercial structure. Our sales and clinical support teams are in place. And we feel this combination of an experienced capital sales team and clinical expert support team is the right approach to drive adoption. The team remains focused on the core U.S. market opportunity building relationships and executing contracts with U.S. hospital systems with a specific focus on multi-system placement opportunities. Clinically, our field team remains focused on selling subsystems within the broad critical care opportunity for new imaging while our innovation and clinical evidence teams are setting the stage for much broader use in the future. Internationally, we maintain our small commercial footprint, but see compelling opportunities for future expansion into new markets. We remain excited about CE marking which we received in February of this year. We also see the immense long term opportunity in low and middle-income countries through the work that hospitals affiliated with the Bill & Melinda Gates Foundation are undertaking with Swoop in Africa and Asia. And lastly, we continue to explore the potential to enter the regulatory process in China. All that said, we remain focused on the U.S. as our number one commercial priority for this year. Finally, as it relates to our commercial process, our commitment to meeting the highest standards for data protection and information security for our customers is paramount. We were pleased that in the first quarter of this year, our key platform achieved record high trust with space two years of certification. We believe this will streamline the information security reviews associated with contracting and hospital implementation. Now turning to our first quarter results. I'm pleased to announce that we achieved record revenue of 2.6 million and 10 commercial Swoop system placements in the first quarter of 2023 driven largely by placements to new U.S. customers. I am incredibly proud of our team and remain optimistic about our commercial pipeline for the future. Alongside our three strategic pillars, we remain laser-focused on spending discipline. We continue to implement initiatives in support of cash runway extension while investing in innovation, clinical evidence and commercial expansion. We continue to foresee a cash runway for the business through 2025. Now turning towards 2023 revenue outlook. We are maintaining our revenue guidance for the full year in the range of $10 million to $14 million. In line with our disciplined approach to spending, we're also maintaining guidance for cash burn of $40 million to $45 million for the full year 2023. I want to reiterate that fundamentally for Swoop, our access and affordability as well as our commercial progress over the last two years show that our clinical value proposition with customers is strong. As mentioned in our last earnings call, we implemented a new pricing model for the Swoop system in early 2023. Our guidance indicates a gradual continued increase in the average selling price in 2023 relative to 2022. I will now turn the call over to Brett Hale, our Chief Administrative Officer and Chief Financial Officer to review our first quarter performance and discuss the financial outlook in greater detail.

Thank you, Maria. Turning to our financial results for the first quarter of 2023. Revenue for the quarter ended March 31, 2023, was $2.6 million, compared to $1.5 million in the first quarter of 2022. Gross profit for the first quarter of 2023 was $1.2 million compared to $0.1 million in the first quarter of 2022, reflecting a 44% gross margin. R&D expenses for the first quarter of 2023 were $5.5 million compared to $8.3 million in the first quarter of 2022. Sales, general and administrative expenses for the first quarter of 2023 were $8.7 million compared to $15.5 million in the first quarter of 2022. Net loss for the first quarter was $12.2 million, equating to a net loss of $0.17 per share, as compared to a net loss of $23.8 million or a net loss of $0.34 per share for the same period of the prior year. Our cash burn in the first quarter was $13.4 million, and we ended the first quarter of 2023 with $104 million in cash and cash equivalents. Turning to our 2023 outlook. Based on the progress and current trends of the business, we are maintaining full year expectations for revenue in the range of $10 million to $14 million. As Maria mentioned, the Swoop clinical value proposition with customers is strong. The new pricing is now in effect. As we mentioned last quarter, we will not be providing an exact average selling price per unit volume expectation. Our guidance is predicated on the assumption that the Swoop system pricing will continue to increase in 2023 relative to 2022. And based on our position in the market today, we remain confident in that steady price improvement. To help you with modeling, please note we still expect our second half to be stronger than our first half as our new sales team gains experience and continues to drive the pipeline. For the year, we now expect gross margins to be approximately 40% to 50% as we begin recognizing scale and average Swoop pricing moves gradually higher. Lastly, we are maintaining expectations for total cash burn of $40 million to $45 million for the full year 2023. This incorporates expectations for continued investment in R&D and substantially streamlined investments in SG&A while maintaining customer-facing resources to drive adoption and growth. In line with this, we have allocated a greater relative portion of CapEx spending to R&D in 2023 versus the prior year, approximately 40% to 50% of total OpEx dollars. We will continue to focus on our three strategic pillars and maintain spending discipline as we realize the benefits of our recent right-sizing and reorganization. As we shared in March, we are excited about the momentum we are building for the remainder of the year and beyond. We are pleased to have the cash and flexibility to invest in the right areas and afford the business the appropriate runway to execute post-reset.

At this point, I'd like to turn the call back to Maria for closing comments. Thank you, Brett. I'm proud of the progress that Hyperfine team has made in recent weeks and months and I am very bullish about what we can deliver. Just a week ago, I attended the ASNR seminar in Chicago and was able to witness firsthand the interest that Swoop is drawing from clinicians, as well as the patient care conversations that continue to open opportunities for Swoop where conventional MRI is not practical or not available. The opportunity for Hyperfine is increasingly compelling as we develop use cases for ultra-low-field MRI and expand geographically. I am confident that we will have exciting progress to discuss with you all in future calls. With that, I want to thank you for your time and open up to any questions.

Thank you. Our first question comes from the line of Larry Biegelsen with Wells Fargo.

Good afternoon. Thanks for taking the question, and congrats on a good start to the year. Just a few for me here. First, you beat consensus and I know there are only a few estimates by about half a million dollars. And you're on a run right now with over $10 million. So why not raise the low end of the guidance range? Was there anything kind of one-time benefit in Q1? Then I had a couple follow-ups?

Sure. Thanks for the question and good afternoon. I think it is really about being prudent. As we said last call, we have just put in place new sales leadership. We have also hired a relatively new sales team. So I'm particularly very pleased with the momentum I am seeing with the new reps. But I want to ensure that they have a little bit more runtime before we start feeling really confident in how they're predicting quarters to come. There was nothing there that was one time. We have those two orders that we continue to deliver a little bit every quarter, and that just continues on the same pattern. So it was a strong quarter in the U.S. It had a little bit of contribution from international, and a little bit of contributions from Gates. I just want to make sure that we give our new leadership and professional team a little bit more runtime until we can be more confident about where we're going to land at the end of the year.

That's fair. A couple follows. One on the Action PMR trial. How long do you think that will take to enroll? What's the follow-up there? How long before we potentially see data?

Okay. So it's a little hard to predict. We're doing this as we continue to improve what I would call our offering on the stroke side. So our first order of business with that evaluation is to ensure that our latest software, which is going to be more advanced than the one that is commercially available, can effectively detect strokes in the acute setting. We need to do a little bit more work to shorten the time it takes to gather those sequences, those images. So we will be continuing on that development work and want to actually include faster sequences at some point in time into the Action PMR. There really is no follow-up to the study, as all of it is really in the acute setting. The ability to detect stroke and make clinical decisions for the patient in this evaluation is critical. So there’s no timeline for follow-up data. But I want to be a little bit prudent that our enrollment may take a little longer. So I want to make sure that we have the opportunity to incorporate the latest software, which is now in beta testing, and also faster sequences that are currently in development and will be available later in the year.

That's fair. And just one more for me. Considering the two Alzheimer's drugs that have shown positive data recently and the fact that reimbursement may require four MRIs per year, are you seeing increased interest in your technology because of that? What are you doing to capitalize on that opportunity? Do you need to conduct an equivalent study with standard MRI? Do you need to partner with a company? I'd love to hear your thoughts on that. Thank you.

Excellent question. Thank you, Larry. It definitely presents a phenomenal opportunity for us, and you are right that there is a Biogen drug that received conditional approval a few months ago, which should lead to reimbursements and infusions starting this fall. There are even more attractive therapies coming in behind them, I believe from Lilly. We've been deeply engaged in discussions among the clinical community concerning this topic. Some current users of our system believe that we can play a role in the initial triaging of those patients as they are monitored with multiple scans, sometimes even more than four a year. So we're working at the individual center level. There is also an ASNR working group that has focused on this topic; they had a meeting last week and major MRI manufacturers were there, as were we. We're learning how the field from a clinical perspective is not fully aligned regarding whether an ultra-low-field scanner can be as effective. We are reaching out to companies to explore partnership opportunities. We're also working on an Alzheimer's package that may include two components: one, a package of sequences we develop separately, and then combining them into protocols for clinical usage. Additionally, many of the scans will be interpreted by clinicians who may not be traditional MRI specialists, but rather professionals in dementia clinics or geriatric care. Several software companies are looking to standardize trend and monitoring reports to understand patient evolution over subsequent doses of the drug. To summarize, we are closely monitoring everything happening in this space. While I can't yet quantify the magnitude of the opportunity and its timing, we're committed to pursuing it vigorously, and I hope to provide more clarity on this in the coming months or quarters.

Okay, thank you so much.

Of course.

Thank you. Our next question comes from the line of Vijay Kumar with Evercore ISI.

Hi, this is Kevin on for Vijay. Just on the gross margin at 43% in the quarter, can you talk to the drivers behind that number? I know in the past you've pointed to price, volume, and costs as the overall drivers. But can you provide any color from a device versus services perspective? Is there any color there and is it about 50% device margin and about 20% service margin?

I think I'm going to let Brett respond to that. Your line was a little hard to understand.

Yes, I'll walk through this and clarify if I don't capture the full essence of the question. The question was effectively on margin and the drivers and if there were any subcomponents. The increase in margin we’ve seen sequentially year-over-year is mainly a direct result of the pricing we've been able to realize as a business. We do break out the margin or the device and the service components that may vary over time. However, the vast majority of our revenue comes from device sales, and you can think about the average selling price playing a significant role in that. Regarding the service margin, we’ve guided to the 40% to 50% range for the full year. We landed kind of in the middle of that here for Q1.

Thank you. Our next question comes from the line of Neil Chatterji with B. Riley.

Hey guys, thanks for taking the questions. I might have missed this, but just on the sales funnel installs for the quarter. I know there were some that slipped from the fourth quarter. Did any of those hit in the first quarter, and what's the kind of expectations for those?

Sorry, I'm not sure I got your question. You were talking about whether any deals that slipped from Q4 closed in Q1? Could you repeat that?

Yes, that and then how that's tracking.

Okay. So there were some deals that took longer than expected and didn’t close in Q4, but ended up materializing in Q1. That’s somewhat typical; our deal flow is strong, but deals can take longer, averaging about six months. Other times, they may take longer due to security scrutiny or other considerations. Overall, I feel Q1 results were good, and I have confidence in our pipeline. While I don’t see deals shortening, I do see it as robust and well-distributed across all of our U.S. territories, with positive early results from some of the new reps who seem to be hitting the ground running, although we need to give them time to become fully familiar with their sales processes.

Got it. Great. Also, just to clarify on your gross margin guidance of 40 to 50. I'm curious about the cadence—how to think about that relative to Q1? Should we expect stronger margins sequentially through the year? How should we think about that?

Yes. I'll take that, Neil. As we discussed in our prepared remarks, we anticipate gradual increases in pricing throughout the year. So you can think about margins trending upwards correspondingly. Keep in mind that mix does impact margins, given our three different channels: U.S. direct commercial, our international distributors, and units associated with King's College.

Great. One last question: any updates on the Viz.ai partnership? Is there any progress there?

We continue to make progress as expected. We are gearing towards starting pilot evaluations in accounts with the technology development, focusing on integrating our images into workflows and ensuring that the Viz.ai platform can effectively manage patients using our images. I can’t provide an exact timeframe for the go-live with some of these accounts, but this continues to move forward.

Great, that's it from me. Thanks.

Thank you.

I would now like to hand the call back over to Hyperfine CEO, Maria Sainz for any closing remarks.

Thank you very much for your interest in Hyperfine. I look forward to updating you again in a quarter. Talk to you soon.

Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.