ClearPoint Neuro (CLPT) Q2 FY26 earnings call: guidance and Q&A

Can you elaborate on the strategic reorganization, specifically regarding sales reps moving to clinical support, and how this impacts 2027 growth?

Management explained the shift towards clinical support roles due to the unique B2B model with pharma partners, where products are kitted with drugs. This requires a different type of salesperson focused on clinical support for high-value procedures. They projected high teens to 20% growth for 2027, with potential acceleration from CAL GLP studies and commercial approvals leading to stocking orders.

“it's not a massive change to what we had originally planned, but it is a reflection on, you know, what does the company and the commercial team need to look like, you know, two, three years out in the future? You know, the reality is is that our company and our business model is very different than a traditional device company.”

asked by Frank Pekkanen, Lake Street Capital Market · answered by Joseph Burnett

Can you quantify the size of the GLP statement of work?

Management stated the first GLP services statement of work is in the 'multi-million dollar range,' with revenue recognition staged as study phases are completed.

“Yes, I don't want to give away too much confidential information, but I would say this first version is split into a few different statements of work, and the total is in the multi-million dollar range.”

asked by Frank Pekkanen, Lake Street Capital Market · answered by Joseph Burnett

Can you break out organic growth versus Aeroflow revenue in Q2?

Management provided Aeroflow revenue for Q2 FY26 as $2.1 million from disposables in neurosurgery navigation therapy and $350K from capital equipment and software, totaling $2.45 million.

“Yes, so in the second quarter, ERAflow was 2.1 million disposables in the neurosurgery navigation therapy line and about 350K in the capital equipment and software. Perfect. The 2.45.”

asked by Frank Pekkanen, Lake Street Capital Market · answered by Unknown Speaker

What is your confidence level in scaling clinical capacity to avoid bottlenecks, and what are the key milestones?

Management expressed high confidence, citing over 30-40 trained clinical specialists already in place and ongoing training. They highlighted the 'clear trial program' for site readiness, with 15 centers already qualified, and the ability to accelerate hiring for Aeroflow if clinical trials are positive.

“Yes, thanks for the question, Tom. I'm very, very confident that that would not be an issue. I mean, even if you looked at our clinical support team and we have in place today, I mean, we have more than 30, maybe even 40, uh, trained clinical specialists at ClearPoint that are capable of doing sort of what I would call the basic navigation cases.”

asked by Tom Steffen, Stifel · answered by Joseph Burnett

What is the capacity for Unicure's AMT 130 launch, max patient support, and the revenue opportunity for ClearPoint in the first 1-3 years?

Management stated the goal is to avoid being a bottleneck, with hospital scaling being a key factor. They noted 15 centers are already qualified to perform 1-2 procedures per week. Revenue per Unicure procedure is estimated at $15,000-$25,000, with internal modeling across all pharma partners using a range of $12,000-$15,000 per patient.

“I mean, if we can get to 20 or 30 of these centers that are each willing to commit, you know, one to two cases a week, you know, which is 50 to a hundred cases a week, You know, you can imagine getting to a ramped up procedure type pretty quickly here. Oh, and the second part of your question there, Tom, as well, is, you know, if you think about the revenue that we generate from a typical Unicure procedure based on navigation cells as well as cannula cells, you know, it's in that anywhere from $15,000 to $25,000 per procedure.”

asked by Tom Steffen, Stifel · answered by Joseph Burnett

How much incremental business capacity and breadth/depth of services does the new CAL facility provide?

Management outlined three growth vectors: increased basic capacity, GLP capability for larger and higher-margin studies, and new services like histology. They estimated the new facility could surpass $60 million in annual capacity, a significant increase from the prior $8 million capacity.

“You know, we believe internally that, you know, this new facility with GLP, with all these additional services could surpass $60 million or so at this facility. So that's the level of scale.”

asked by Matthew Blackman, TD Cowan · answered by Joseph Burnett

What is the role of the robotic platform, its specific use cases, and how will it impact your business model and economics?

Management explained the robotic platform is designed for cranial procedures, differentiating it from competitors focused on spine (95% of features). The goal is to be the vendor of choice for dedicated cranial rooms. They discussed various deployment models (capital equipment + service contract + disposables vs. per-procedure fee) and noted that while the economics might show up differently, the per-procedure revenue to ClearPoint is not expected to change significantly.

“You're still going to do tons of spine procedures, but you're, you don't, as a hospital, you don't need to be focused on saying, well, I want a robot that does spine and cranial and all these other things, because that room in your hospital can be dedicated to cranial and we want to be the vendor of choice in that situation.”

asked by Matthew Blackman, TD Cowan · answered by Joseph Burnett

Have commercial ASP negotiations begun for cannula/navigation, what is the commercial premium, and is there clarity on co-labeling (cannula vs. both)?

Management confirmed active negotiations for commercial pricing and supply agreements. They explained that co-labeling creates opportunities for extra value, including higher ASPs for commercial launch compared to clinical trials, and potential royalties on the drug (though higher ASP is often easier to negotiate). They also mentioned offering protections like building redundancy or IP escrow.

“Yes, sure, thanks, Anderson. So the first question I would say is, yes, we are actively in negotiations with numerous partners around commercial pricing and supply agreements. We need to remember that in many cases, the cannula and possibly, in some cases, the navigation could be co-labeled devices.”

asked by Anderson Schock, B. Reilly Securities · answered by Joseph Burnett

Update on CAL capacity and whether large studies can begin now or are limited until GLP capability in H1 2027.

Management stated they are taking orders for time slots. The current 2026 guidance does not include execution of large studies. They expect to showcase the facility in H2 2026, with larger studies running through in H2 2027, after equipment installation and full GLP operationalization.

“So the way we're thinking about it is that, you know, in the first, in the second half of this year, in 2026, we are showcasing the facility. We're bringing biopharma partners through, uh, we're emphasizing our capabilities. We're introducing them to the team.”

asked by Anderson Schock, B. Reilly Securities · answered by Joseph Burnett