8/3/2026

speaker
Operator
Conference Operator

The comments made on this call may include statements that are forward-looking within the meaning of securities laws. These forward-looking statements may include, without limitation, the company's plans, prospects, and strategies, and its beliefs, estimates, or projections regarding future revenue and results of operations. You are cautioned not to place undue reliance on forward-looking statements which speak only as of the date on which they are made. Actual results or trends could differ materially. The company undertakes no obligation to revise forward-looking statements for the new information or future events, except as required by law. For more information about the company's risks and uncertainties, please refer to the company's filings with the SEC, including the company's recent filings on Form 8K, Form 10K, and Form 10Q. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. And now I'll turn the call over to Joe Burnett, Chief Executive Officer. Thank you. You may begin.

speaker
Joe Burnett
Chief Executive Officer

Thank you. And as always, thank you to all the investors, analysts, and biopharma partners listening to today's call. We remain both committed to and focused on developing a complete neuro ecosystem capable of delivering various minimally invasive treatments, including cell and gene therapies to the brain. We believe that this approach will finally unlock hope for the patients and their families who are battling these frightening neurologic disorders and who today have very few options to choose from. This is one of the largest unmet needs in all of medicine, and we at ClearPoint believe that we can play an important, if not essential role in this exciting future. The second quarter of 2026 in itself has been an exciting one and possibly one of the most important series of events in our history. While our long-term vision remains unchanged, anchored by our four pillar growth strategy, There has been substantial progress leading us to up prioritize certain parts of the strategy and to take advantage of this new information from the last few months. So today, instead of looking to the horizon and reconfirming our long-term strategy, I will focus on these three most important and elevated priorities that are right in front of us. These three activities will represent the largest time and financial investment for the second half of this year. First, we have all seen regulatory updates from pharma partners demonstrating an accelerated pathway to phase three trial enrollment and even commercial approval. This revised potential schedule is much faster than what we believed just six months ago and once again has highlighted the need to pursue commercial readiness activities in support of our partners' global launch plans. Second, as of July, we have now taken possession of the 30,000 square foot Cal preclinical facility in Torrey Pines, California, which includes our analytical lab space. This milestone has enabled us to sign our very first statement of work for GLT services, which we expect to complete in the first half of 2027 when all of our equipment and procedures are in place. We believe that this asset will fuel growth in our preclinical services business, starting here in the second half of 2026, with continued growth in 2027 and beyond. And third, the announcement of our partnership in Focused Ultrasound, which when combined with our in-development robotic system and Harmony 1.0 control software, will be designed to assist our partners in the next phase of drug delivery growth after approval, which will be commercial expansion, scale, and efficiency. These three foundational activities have become paramount over the last few months and warrant a greater demand of our focus and our attention. I will now hand the call over to Danilo D'Alessandro, our CFO, to review financials in the quarter, after which I will spend some time detailing the second half 2026 priorities. Danilo?

speaker
Danilo D'Alessandro
Chief Financial Officer

Thank you, Joe, and thank you all for joining us today. Looking at the second quarter 2026 results, Total revenue was $10.9 million for the three months ended June 30th, 2026, and $9.2 million for the three months ended June 30th, 2025, which represents 18% growth versus the second quarter of 2025. Our revenue is made up of three components, biologic and drug delivery, neurosurgery, navigation therapy, and capital equipment and software. Biologics and drug delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products. Biologics and drug delivery revenue decreased 15% to $4 million in the second quarter, down for $4.7 million in 2025. This decrease was mainly due to a decrease in product revenue of $0.9 million due to a single customer order that occurred in the quarter of the prior year and did not recur in the current quarter. BNDD service revenue increased $0.2 million from prior year. Neurosurgery navigation revenue consists of commercial sales of disposable products related to cases utilizing the ClearPoint system, the PRISM laser system, and Aeroflow. This revenue grew to $5.6 million for the second quarter of 2026, driven primarily by additional revenues due to sales of the Aeroflow product. as well as the introduction of our 3.0 operating room navigation software which has positively impacted procedural volumes in the operating room during the three months ended June 30th, 2026 compared to the same period in 2025. Capital equipment and software revenue consisting of sales of our reusable hardware and software and of related services increased 24% to $1.3 million in the quarter. from $1 million for the same period in 2025 due to an increase in the placement of Pierpoint navigation systems, PRISM laser units, and airflow control units. Gross margin for the second quarter of 2026 was 62%, an increase of 2% compared to 60% in Q2 2025, mostly related to a decrease in excess and obsolete inventory. Research and development costs were $4.6 million for the three months ended June 30th, 2026, compared to $3.8 million for the same period in 2025, an increase of $0.8 million or 21%. The increase was due primarily to higher personal cost of $0.8 million. Sales and marketing expenses were $6.8 million for Q2, compared to $4 million for the same period in 2025, an increase of $2.7 million or 68%. This increase was due primarily to additional personal cost of $1.8 million and increases in travel cost of $0.3 million, resulting from the expansion of our clinical and sales teams. The increase was also driven by additional amortization expense of acquired intangible assets of $0.2 million and marketing material cost of $0.2 million. General and administrative expenses were $5.6 million for the second quarter. an increase of $2.2 million or 64%. This increase was due primarily to increases in occupancy costs of $0.7 million, professional service fees of $0.5 million, personal costs of $0.3 million, general corporate costs of $0.3 million, and IT and software costs of $0.2 million. As of June 30th, 2026, we had cash and cash flow equivalents totaling $29.4 million as compared to $45.9 million at December 31st, 2025. The cash reduction was primarily due to the operational cash burn of $15 million through Q2 2026 and $2 million due to payments for taxes related to net share settlement of equity awards. We do expect the operational cash burn to decrease in the second half of the year as we benefit from the completion of the ERIS integration. I'd like now to turn the call back to Joe.

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