管理層發言
Good afternoon, and welcome to the Spectral AI Inc. Second Quarter 2026 Conference Call. Please note, this event is being recorded. I would now like to turn the conference over to Devin Sullivan, Managing Director of the Equity Group. Please go ahead.
Thank you, Gary. Good afternoon, everyone. Thank you for joining us for Spectral AI's 2026 second quarter financial results conference call. Our speakers for today will be Vincent Capone, the company's Chief Executive Officer; and David McGuire, Chief Financial Officer. Before we begin, I'd like to remind everyone that during this call, certain statements made are forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the company's strategy, plans, objectives, initiatives, and financial outlook. When used during this call, the words estimates, projected, expects, anticipates, forecasts, plans, intends, believes, seeks, may, will, should, future, propose, and variations of these words or similar expressions or the negative versions of such words or expressions are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions, or results and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside the company's control that could cause actual results or outcomes to differ from those forward-looking statements. As such, listeners are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the Risk Factors section of the company's filings with the SEC, including the registration statement and other documents filed by the company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. With that said, I would like to turn the call over to Vincent Capone, Spectral AI's Chief Executive Officer. Vince, please go ahead.
Thanks, Devin, and thank you all for joining us today. We issued our earnings release this afternoon, which contains additional details of our operating results, and we will also file our Form 10-Q with the SEC this afternoon. We've had some significant developments since we last spoke. In May, we achieved a major benchmark with the FDA de novo clearance for our DeepView System for the burn indication, marking a major milestone in Spectral AI's history. This clearance validates the strength of our science, the groundbreaking research and development efforts and also sets the stage for our company's transformation to a commercial organization. Over the next several years, our main focus will be on a disciplined commercial launch in the United States and abroad. We will also focus on continued expansion of clinician awareness of the DeepView System through our triage and treatment outcome study initiative as well as expanding our commercial viability and infrastructure, further software and hardware advancements in our technology and the continued work on the expansion of additional indications on tissue diagnostics, which will lay the foundation for sustainable long-term growth and an expanded position within our marketplace. An important part of that execution strategy is finding the right people. At the beginning of our last earnings call, I welcomed David McGuire as our new CFO. On today's call, I would like to welcome Darcy Bajko as our new Chief Commercial Officer. Darcy brings significant market experience to our organization from her time at Integra and Smith & Nephew in particular, and her recent appointment reflects the continued strengthening of our leadership team. I will be working closely with Darcy to execute on our commercial strategy, accelerate our product launch schedule and enhance alignment across our sales, marketing, market access and reimbursement strategy. I am pleased to welcome her to Spectral AI. Our DeepView System is a truly first-of-its-kind technology cleared by the FDA in the absence of any predicate device. It is the culmination of more than $250 million of nondilutive governmental funding over the last 13 years and a tireless effort from our executive and research teams and collaborating clinicians. I'd like to talk for a few moments on our regulatory pathway and successes to date. Since the inception of the FDA's Breakthrough Devices Program over a decade ago, nearly 1,300 medical devices have met the Center for Devices and Radiological Health's rigorous standard to receive breakthrough designation. Spectral AI received this designation in 2018. Today, our DeepView System is one of only 193 devices, or 15%, that has successfully navigated a novel regulatory approval process to commercial market authorization through the de novo pathway. While the FDA clears over 3,000 standard 510(k) applications every year, it grants an average of just over 40 de novo authorizations, fewer than 2% of all approvals, putting our technology in an incredibly exclusive tier of true medical innovation. This rare milestone is a powerful testament to the clinical rigor, disruptive capability, and significant competitive advantage that our DeepView System brings to the future of wound care. We are excited to introduce this product across the burn marketplace in both the United States and abroad. The DeepView System provides an immediate assessment of whether a burn wound will heal on its own or require significant medical intervention, eliminating both undertreatment, which can take the form of delayed surgery and extended length of stay, and overtreatment, where patients are subject to an avoidable surgery or graft procedure. Our wound assessment abilities are ground-truthed by over 340 billion pixels of clinically validated burn images. I cannot stress enough the competitive moat that both this burn biopsy library and our patent portfolio provide to our company. These attributes underscore just how novel our approach is to burn assessment, while emphasizing the potential of this AI-driven diagnostic imaging platform to redefine the standard of burn care in triage and treatment. So with the FDA clearance in hand, where are we going? Our commercial model is designed around two complementary revenue streams and a staged adoption path that we believe supports both near-term monetization and long-term recurring growth. At the point of device placement, we expect to generate revenue through capital purchase or lease, with each installation creating an opportunity for recurring annual software and services revenue with a minimum three-year term that compounds as placements grow. Importantly, we also understand the factors that drive revenue timing. Placements in prior clinical sites, we believe, can move the fastest and accelerate adoption while new installations typically follow a longer capital and procurement cycle. The first 30 U.S. installations will benefit from significant support from our partners at BARDA. The burn market opportunity offers near-term sales and a multi-year commercial runway. To that end, while we see a meaningful long-term opportunity in over 200 high-value facilities, our initial focus will be on deploying up to 30 systems under the BARDA CLIN II part of our multi-year Project BioShield contract. Under this contract, through June 30, 2027, we will be placing our DeepView System into routine care use across U.S. burn centers, trauma centers, and emergency departments, with some centers supporting our clinical validation work. In connection with our international sales strategy, we are in the process of updating our UKCA burn assessment approval, which we secured in 2024, to reflect the improved algorithm, hardware, and software included in our FDA-cleared device. We anticipate receiving this expanded UKCA clearance in the fourth quarter of this year, after which time we will commence initial sales and placements of the DeepView System in either the U.K., Australia, or within the Gulf Cooperation Council countries. In the U.K., we have also initiated our head, hands, and feet study to support a label expansion of the DeepView System across all markets. Domestically, we are also in the final stages of initiating a triage and treatment outcome study to demonstrate that the DeepView System's wound assessments improve surgical precision and accelerate treatment decisions, leading to a better overall patient care journey and a reduced length of stay for these patients. We expect to launch this study in the fourth quarter of 2026 with 12 centers across the United States. We remain steadfast in the improvements in patient care and reducing length of stay for patients through our diagnostic advancements. I want to express that we are also well capitalized to execute on our strategic priorities. As of June 30, 2026, our balance sheet included $14 million of cash with a manageable debt maturity and access to over $60 million of additional nondilutive funding from BARDA. Longer term, I also want to emphasize that we see our DeepView System as a platform technology. As previously noted, we have delivered a prototype of our handheld device to MTEC last quarter as part of our existing Department of Defense contract. We are also working on the expansion of our total body surface area burn calculation. Those capabilities use the DeepView System's imaging and AI platform to quickly and objectively quantify how much of a patient's body is burned. This would provide a standardized data-driven input for triage, fluid resuscitation, and treatment decisions, which are especially valuable in complex or mass casualty situations. Our team remains deeply focused on advancing this technology by building on these developments to pursue potential new indications, including critical limb ischemia, amputations, diabetic foot ulcers, and others. Our team is energized by our FDA approval and deeply motivated by the opportunities that lie ahead for us. With the FDA de novo clearance for our DeepView System behind us, a clear commercialization roadmap in place, and a full bench of experienced leaders to execute on our strategy, I believe we are well positioned to define Spectral AI as a true commercial-stage platform technology company in the quarters and years ahead. With that, I'll now turn things over to David for a review of our financial results for the second quarter of 2026.
Thanks, Vince. As Vince noted, this was a transitional quarter for Spectral AI, one that reflects our move from a purely development-stage company towards commercial sales, as we remain confident in our ability to continue our R&D efforts while building this commercial business. Starting with the top line, R&D revenue for Q2 2026 was $3.5 million compared to $5.1 million in Q2 2025. This decline was anticipated: our BARDA work has now moved into a cost-sharing phase and with burn validation complete and the device cleared, we are also in between major study phases. We expect BARDA activity to further ramp up in support of this outcome study primarily in Q4. Revenue from our other U.S. government contract did also decline as we completed the work under our MTEC contract. The BARDA cost share reduces revenue and gross margin that we recognize on this program, and that effect continues through the follow-on phase. It reflects a deliberate decision to co-invest alongside BARDA in the features we expect to carry the most commercial value. The same relationship also funds our entry into the market. BARDA support underwrites the first 30 U.S. system placements as the initial installed base is being built with substantial nondilutive funding behind it. Gross margin for Q2 2026 was 31.6% compared to 45.2% in Q2 2025, reflecting this cost share. For the first six months, gross margin was 41.8% compared to 46.4%. Both reflect development revenue only. Our commercial model is different: device placement, purchase or lease, plus recurring software and service revenue on a minimum three-year term. We completed a third-party pricing study during the quarter, and based on that work and preliminary customer conversations, our early indication is that the market will support pricing consistent with margins well above those our development work carries today. We will refine that as we move through launch, but as placements build, we expect a mixed shift to lift our blended gross margin. As we move into commercialization, we intend to give you a clear line of sight into progress. As sales begin, we expect to report system placements and install base, and to break out recurring software and service revenues as it becomes meaningful. Operating expenses for Q2 2026 rose to $5.4 million from $4.4 million in Q2 2025. Beginning this quarter, we changed the presentation of our operating expenses to break out research and development, sales and marketing, and general administrative as three separate lines applied retrospectively to all periods presented. We made that change so investors can clearly see where we are investing ahead of commercialization. On that basis, in Q2 2026 compared to Q2 2025, R&D expenses increased $200,000 to $1.7 million reflecting additional development work on the UKCA mark expansion Vince covered. Selling and marketing expenses increased $300,000 to $700,000 reflecting launch readiness work that includes the third-party pricing study. General and administrative expenses increased $500,000 to $3.1 million, driven primarily by noncash stock compensation tied to equity awards issued during the quarter. Excluding stock-based compensation, general and administrative expense was essentially flat year over year, which we believe speaks to continued cost discipline even as we build out the commercial organization. Total other income for Q2 2026 was $300,000 compared to other expense of $5.9 million in Q2 2025. The change was primarily driven by the non-cash fair value adjustments related to our warrant liability. Net loss for Q2 2026 was $4.2 million, or $0.13 per basic and diluted share, compared to a net loss of $8 million, or $0.31 per basic and diluted share in Q2 2025. The improvement was driven primarily by the non-cash warrant fair value swing, partially offset by lower gross profit and higher operating expenses. Adjusted EBITDA in Q2 2026 was $3.5 million compared to $1.7 million in Q2 2025. The year-over-year change primarily reflects lower gross profit together with increased operating investment ahead of commercialization. With respect to our financial condition, as of June 30, 2026, cash was $14 million compared to $15.4 million as of December 31, 2025. Cash usage during the first half primarily reflected continued investment in R&D and commercialization initiatives, offset in part by the second tranche of our Avenue Capital facility. On that facility, in June, we drew the second tranche of $6.5 million bringing us to a full $15 million commitment. Drawing that tranche was contingent upon FDA clearance of the DeepView System and achieving that milestone also extended our interest-only payment period from a minimum of 15 months to 24 months with the facility maturing in March 2028. That means no principal payments till March 2027, which pairs well with our $14 million cash position as we fund our commercial launch. We remain focused on disciplined capital allocation as we advance towards commercialization. As of June 30, 2026, total debt was $14.9 million with 32.2 million shares outstanding. Taken together, $14 million of cash, no principal payments due through March 2027 and continued access to substantial nondilutive BARDA funding, we believe we have the resources to execute our commercial launch. We also have our equity facility with Yorkville available if we choose to use it. I look forward to engaging with many of you in the quarters ahead. With that, I'll turn the call back over to Vince.
David, thank you. Before turning things over to questions, I want to address our 2026 outlook. We are going to reiterate a revenue guidance of approximately $18.5 million, which includes the effect of the new BARDA funding from March of this year. This guidance does not include any significant contributions from sales of our DeepView System. With that said, I'll open the floor to questions.
分析師問答
Operator provides instructions. The first question today is from Luke Horton with Northland Securities.
I just wanted to start on what the sales force looks like today: how many salespeople do you think you need to hire and what's the ramp for them to get familiar with the product for this initial 30-system rollout?
Luke, thanks for the question. Today our sales force really includes two people: our new Chief Commercial Officer and the head of our U.K. operations for overseas sales. Budget-wise, we have allocated at least an additional two people to assist in that effort. I will be spending some of my time working with that team as we look to facilitate installations across a number of clinical sites as well as other sites in the fourth quarter of 2026.
Okay, got it. With the MTEC contract now complete, what's the status of the handheld device or any feedback there? Is there a path to a follow-on government contract for that?
That's a good question. We're quite pleased with the work we have done with our Department of Defense contract through the MTEC consortium. We delivered a prototype to them earlier this summer, and we performed every outstanding item in the MTEC contract. At this point, MTEC is positioned to evaluate what's next for their allocation of capital for their 2026-2027 budget, which launches in October of this year. Our development work on the handheld has been quite strong. We continue to see potential opportunities for the handheld, both commercially and potentially with military applications. I just came back from the MHSRS conference last week. There are opportunities given current global conflicts where a handheld capability could be valuable.
Okay, got it. And then lastly, as you commence this commercial strategy and roll out the first devices, how are you building relationships with hospitals and burn centers? Is BARDA helping with relationship development or strictly funding? What does the timeline for building those relationships look like?
Relationship building is something we have strong capabilities for. We have done two very large studies, including what I believe was the largest burn validation study done in the United States. Our clinical team has strong outreach to a number of sites around the country, and we will leverage those relationships to open the door for product procurement. We've already started that effort. We have strong relationships across the burn community and strong key opinion leaders. BARDA has been a fantastic partner for us with nondilutive funding, but we do not rely on that relationship for commercial inroads. BARDA will support our commercial efforts and support the centers because we both share the same goal: to roll out devices across the country so that in the event of a domestic mass casualty event, the United States is prepared to handle potential burn victims in a speedy and well-diagnosed manner.
The next question is from John Vandermosten with Zacks.
Vince and David, now that you've got a Chief Commercial Officer on board and have had clearance for a few months, what are you seeing as the main hurdles to deployment?
John, thanks for the question. Deployment is new for this organization, and Darcy has significant experience in this area as do others on our team. Going through procurement in centers where we don't have a strong relationship will lead to a longer procurement window as we work through new AI committees and the procurement process in general. We're learning as we go, but in centers with strong KOL support, we are confident we will get through procurement fairly quickly. In other centers, we need to work through both procurement and cybersecurity and AI component committees. We're working through that, and we feel confident in our ability to meet our internal rollout timeline.
Okay. You mentioned potential deployments in the Middle East; how is that progressing? Are there other geographies showing interest beyond the U.K., Australia, and the United States?
We have spent time with devices in Australia and the U.K. on an evaluation basis, and we expect those to be among the first to adopt the technology. There are opportunities in other parts of the world that we view as potential low-hanging fruit. We've had great experience in the U.K. and Australia, and those markets, combined with one or two centers in the U.K., will likely be the first international installations. There may be others, but we see that as the near-term window, and we're hopeful for progress in 2026.
Last question: among potential customers, do most facilities already have a burn device like Laser Doppler Imaging (LDI) or no technology at all? Who is more interested: those familiar with that kind of technology or those without anything?
I would argue that every burn center in the United States either has nothing or has a technology that is quite antiquated. The placement of our device is a significant step forward in diagnostic imaging for these sites. LDI devices are somewhat prevalent, mostly in the U.K., and there's very little adoption in the United States. Clinicians who participated in our burn validation study understand the capabilities, and we're excited to get started and place devices in centers to both protect the country in the event of a mass casualty and to improve patient care. We've been in this field for 17 years, and we're eager to improve patient outcomes and care.
This concludes our question-and-answer session. I would like to turn the conference back over to Vince Capone for any closing remarks.
Thanks, Gary. In closing, I would like to thank our shareholders again for their support of our company. We're excited about what lies ahead for us. I also want to reiterate that we're thankful for our clinicians' support and collaboration, and most notably we are excited to offer this technology to patients across the country and around the world who will benefit from this breakthrough technology in the near future. Thank you all for your attendance and interest in our company. Have a good evening.
The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.