Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Revenue for Q2 2024 was $246,000, showing growth in sales of consumables and system leases.
- The company entered into an equipment service plan warranty program with two customers, valued at approximately $139,000.
- Net loss improved by 35% to approximately $3.2 million compared to $4.9 million in Q2 2023.
- The pivotal clinical trial for the B-Series OCT with ImgAssist AI is ahead of schedule, with patient enrollment expected to complete in Q3 2024.
- The company achieved its 1,000th paid Perimeter S-Series OCT patient scan, marking a significant clinical and commercial milestone.
Negative Points
- Operating expenses increased to approximately $5.5 million in Q2 2024 from $3.4 million in Q2 2023.
- Cash used in operating activities was approximately $7.5 million, relatively flat compared to $7.2 million in Q2 2023.
- Cash and cash equivalents were approximately $6.5 million as of June 30, 2024, indicating a need for future fundraising.
- The S-Series OCT system is not specifically FDA-cleared for use in breast tissue or other types of cancer margin evaluation.
- The company anticipates needing to fundraise before early next year to maintain operations.
Q & A Highlights
Q: Great to hear on all the activity and kind of six installations year to date. Could you dig into that a little more? Kind of what's the total number of systems that are currently installed and maybe how many kind of net new in Q2?
A: Scott, thanks for joining, good question. So we're up to 12 systems now that are currently installed and earning revenue for us. And four of them, four of the total, have been in the second quarter. So we've been accelerating quarter after quarter, four of those six in Q2. (Adrian Mendes, CEO)
Q: And then maybe a bit on the type of facilities that those kind of recent installations have been in, are they hospitals, surgical centers? And are these new sites? Are these sites that are acquiring their second system or part of national chains or things like that?
A: Yes, they're all hospitals, hospital systems, they actually follow very similar, the same profile, that we have been winning to date. So it's just sort of expansion into the place we've had success already. (Adrian Mendes, CEO)
Q: Got it. That's great. And then I guess on the balance of the year, kind of how you're seeing the pipeline growing and moving through the sales cycle?
A: Yes. Strong pipeline, we expect to see the sort of growth rates continue through the third quarter and fourth quarter, expanding into new facilities, expanding to new states. So I think we're sort of just kind of push -- sort of refer back to something I said earlier is one of the things that we've all been working really hard here, just to make sure we're establishing sort of the foundational structure in the company, that will help us grow sustainably over time. So it's not just like wanting really hard, closing a bunch of deals and then going into a drought. And so we've seen that. When we look at our pipeline, we see things kind of stage nicely through the entire pipeline, through phases and with increasing quantities as time goes on. So we're encouraged that this is a story that's sustainable that we can keep going. (Adrian Mendes, CEO)
Q: That's great. I guess on the trial, fantastic to hear that the recruitment is going faster than expected and should be finished soon, so I guess if the recruitment finish in Q3, could you talk through a bit on when we could expect to see the top line data and then potential FDA submission and approval?
A: Yes. So the hope is that we'll be able to talk about top line data in the fourth quarter, before year-end, and then with the goal of submitting to the FDA early next year, like early Q1. And then we're planning -- right now, we're anticipating approval sometime towards the end of 2025 or early 2026. We have Breakthrough Device Designation. So that, we hope, will help speed things through. Internally, we're sort of preparing everything. I mean, we have been preparing everything, continue to prepare everything, just to make sure there is no wait time between our request from the FDA and when we can submit something or the trial ending and when we can submit something. So one of the biggest, highest priorities we've got in the company is just to get through, to get that Series-B on the market as quickly as possible. (Adrian Mendes, CEO)
Q: Absolutely. And sorry, you broke up a little bit, you're saying kind of data before the end of the year and then submission in Q1.
A: That's right. (Adrian Mendes, CEO)
Q: Got it. And on the white paper, great to see those data in that form. Any other kind of white papers or studies, kind of real-world evidence that you guys are working on to put up there.
A: Yes, absolutely. So like we mentioned, we've got 1,000 patients through right now, and so we've got that data. We've got a few papers going through a peer-reviewed process. The first paper was a white paper. The next ones will be peer-reviewed. We've also set up a registry now, a formal registry. So we're gathering data in a more sort of structured manner, I suppose. So you'll start to see that flow of clinical evidence start to pick up starting later this year and into the future. (Adrian Mendes, CEO)
Q: That's great. Yes, good to get more of that data, especially if it's peer-reviewed. Obviously, it's great to reach that 1,000th scan benchmark. Can you kind of speak to either how many procedures were done in the quarter or what you're seeing from a monthly run rate or a bit about that kind of the utilization and what you're hoping to see going forward?
A: I don't have the precise numbers at the monthly level. It's safe to say that it is increasing. Every new device that we put in the field is also adding. If you recall, one thing that we did since the time I've been here is we really staffed up the clinical team that helps with customers and helps train them and get them onboarded. So a big part of their focus is just making sure that we're getting more and more customers through and our volumes up. So that has been increasing over time on a monthly basis, and we anticipate it to continue to increase. (Adrian Mendes, CEO)
Q: That's great. And I guess lastly, ImgClear, certainly kind of new for me, hadn't heard about that, so good to hear that those product improvements are continuing. So that algorithm kind of didn't need FDA approval and there are just kind of no necessarily costs or anything like that to people you're planning on just rolling that out. And that, I would assume, would be included in the B-Series and that then doesn't impact any kind of the regulatory pathway or any of that process.
A: Yes, that's all correct. It didn't need to go through any sort of regulatory approval. And the most important thing about that, and one thing that I'm really happy with what the team has been able to do, is really start to get this process of collecting feedback from customers and then having engineers work on some of those challenges and solve them and deploy that in the field. And the big one with ImgClear, frankly, is the fact that it does cut down the scan time in the operating room. Every minute counts in the operating room, so that's really great. The team has ideas on how to make that even faster, so that's good. I think we've got a nice product development trajectory on that as well. (Adrian Mendes, CEO)
Q: I guess what would be, with that ImgClear, the kind of average scan time that a surgeon would take?
A: Yes. So from
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
